Chronic Obstructive Pulmonary Diseases:Journal of the COPD Foundation

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The Short-term Impact of Symptom-defined COPD Exacerbation Recovery on Health Status and Lung Function

Posted in: Original Research, Volume 5 | Issue 1

Lindsey T. Murray, PhD1 Nancy K. Leidy, PhD1

Author Affiliations

  1. Evidera, Bethesda, Maryland

Address correspondence to:

Lindsey Murray, PhD
7101 Wisconsin Avenue
Suite 1400
Bethesda, MD 20814
Phone: 301-654-9729
email: lindsey.murray@evidera.com

Abstract

Background: This study examined the short-term effects of symptom-defined exacerbation recovery on health status and pulmonary function in moderate to severe chronic obstructive pulmonary disease (COPD) patients.

Methods: Secondary analyses of pooled data from two 12-week Phase II international, randomized controlled trials using the EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) to identify symptom-defined exacerbations were conducted. Recovery was categorized as recovered, unrecovered (persistent worsening), or censored. Multiple regression analyses were used to test the effect of recovery status on change in the St George’s Respiratory Questionnaire (SGRQ) and forced expiratory volume in 1 second (FEV1) from baseline to Week 12. Evaluating Respiratory Symptom scale (E-RS) scores were used to evaluate change in stable-state respiratory symptoms from baseline to Week 12.

Results: Of 1346 eligible patients, 414 (31%) experienced ≥1 symptom-defined exacerbation; 260 patients recovered from their events, 80 experienced an unrecovered event (persistent worsening), 74 patients had only censored events (excluded). Groups were similar at baseline, with the recovered group reporting significantly worse symptoms (p<0.01). Recovery group and baseline SGRQ were significant predictors of change in health status over 12 weeks (p=0.04; p<0.01); no effects were observed for lung function. Significant between-group differences in change in respiratory symptom severity from baseline to Week 12 were observed (p<0.01), with the persistent worsening group experiencing clinically meaningful deterioration in breathlessness and chest symptoms.

Conclusions: Results suggest some patients have difficulty recovering from symptom-defined exacerbations, leading to a deterioration in health status, dyspnea, and chest symptoms without short-term effects on lung function. Further study of symptom-defined exacerbation recovery and health outcomes is warranted.

Citation

Citation: Murray LT, Leidy NK. The short-term impact of symptom-defined COPD exacerbation recovery on health status and lung function. J COPD F. 2018; 5(1): 27-37. doi: http://doi.org/10.15326/jcopdf.5.1.2017.0166

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Pattern and Adherence to Maintenance Medication Use in Medicare Beneficiaries with Chronic Obstructive Pulmonary Disease: 2008-2013

Posted in: Original Research, Volume 5 | Issue 1

Shawn P. E. Nishi, MD1 Matthew Maslonka, MD2 Wei Zhang, MS1 Yong-Fang Kuo, PhD3 Gulshan Sharma, MD, MPH1,2

Author Affiliations

  1. Division of Pulmonary, Critical Care & Sleep Medicine, University of Texas Medical Branch, Galveston
  2. Department of Internal Medicine, University of Texas Medical Branch, Galveston
  3. Sealy Center on Aging, University of Texas Medical Branch, Galveston

Address correspondence to:

Shawn P.E. Nishi, MD
Division of Pulmonary, Critical Care & Sleep Medicine
University of Texas Medical Branch
301 University Blvd
Galveston, TX 77555-0561
Email: spnishi@utmb.edu
Telephone: (409)772-2436

Abstract

Background: Maintenance medications provide symptomatic relief, improve lung function and reduce the risk of exacerbations in patients with chronic obstructive pulmonary disease (COPD). Despite their proven benefits, limited information exists on maintenance medication use and adherence among users.

Objective: We examined the patterns and factors associated with the receipt of and adherence to maintenance medication in individuals with COPD.

Methods: A retrospective cross-sectional study of 5% of Medicare beneficiaries enrolled in Parts A, B and D with COPD who received maintenance medication from 2008 to 2013 was conducted. Maintenance medication includes: inhaled corticosteroids (ICSs), long-acting beta2- agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) alone or in combination. We examined the proportion of beneficiaries with COPD who had at least one prescription filled for maintenance medication. Among users of maintenance medications, we also examined adherence, defined as proportion of days covered (PDC) ≥80% over the year from the first maintenance medication prescription fill date.

Results: Overall, maintenance medication (LAMAs, LABAs, ICSs and/or LABA/ICS) use increased from 67.8% in 2008 to 72.1% in 2013. The increase is related to increases in use of LABA/ICS, which rose from 41.1% in 2008 to 49.6% in 2013. Factors associated with receipt of maintenance medication include female gender, recent COPD hospitalization (odds ratio [OR] 1.63; 95% confidence interval [CI] 1.54-1.73), oxygen therapy (OR 1.74 95% CI, 1.68-1.81), dual eligibility status (OR 1.45; 95% CI 1.39-1.51), higher education level and evaluation by a pulmonary provider (OR 1.88; 95% CI 1.81-1.96). The overall adherence among maintenance medication users remained flat. The most important factor associated with adherence was dual eligibility status (OR, 1.67; 95% CI: 1.59-1.75).

Conclusions: Receipt of maintenance medications increased during the study period and was higher in those with dual eligibility. Overall, adherence to maintenance medications was suboptimal and remained unchanged.

Citation

Citation: Nishi SPE, Maslonka M, Zhang W, Kuo Y-F, Sharma G. Pattern and adherence to maintenance medication use in Medicare beneficiaries with chronic obstructive pulmonary disease: 2008-2013. J COPD F. 2018; 5(1): 16-26. doi: http://doi.org/10.15326/jcopdf.5.1.2017.0153

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Long-Term Evaluation of the Effects of Aclidinium Bromide on Major Adverse Cardiovascular Events and COPD Exacerbations in Patients with Moderate to Very Severe COPD: Rationale and Design of the ASCENT COPD Study

Posted in: Original Research, Volume 5 | Issue 1

Robert A. Wise, MD1 Kenneth R. Chapman, MD2 Benjamin M. Scirica, MD3,4 David A. Schoenfeld, MD4 Deepak L. Bhatt, MD, MPH3,4 Sami Z. Daoud, MD5 Beatriz Seoane, MSc6 Colin Reisner, MD5 Esther Garcia Gil, MD6

Author Affiliations

  1. Johns Hopkins University School of Medicine, Baltimore, Maryland
  2. University of Toronto, Ontario, Canada
  3. Brigham and Women’s Hospital, Boston, Massachusetts
  4. Harvard Medical School, Boston, Massachusetts
  5. AstraZeneca Research &Development Center, Gaithersburg, Maryland
  6. AstraZeneca Research & Development Centre, Barcelona, Spain

Address correspondence to:

Robert A. Wise, MD
University School of Medicine
5501 Hopkins Bayview Circle
Baltimore, MD, 21224
Email: rwise@jhmi.edu
Telephone: (410) 550-0546
Fax: (410) 550-2612

Abstract

Introduction: Chronic obstructive pulmonary disease (COPD) is a heterogeneous illness characterized by persistent airflow obstruction and exacerbations. Patients typically experience a decline in lung function, increasingly impaired health-related quality of life, and high mortality. Poor lung function and exacerbations are associated with an increased risk of cardiovascular (CV) and cerebrovascular events, and approximately 30% of patients with COPD die from CV‑related disease. Treatment with inhaled long-acting bronchodilators, such as long-acting muscarinic antagonists (LAMAs), is recommended; however, some studies have suggested that LAMAs may increase the risk of CV events. As patients with CV and cerebrovascular conditions are often excluded from clinical trials, an evaluation of the safety of COPD treatments in an at-risk population is vital. Aclidinium bromide is a LAMA approved for the long-term maintenance treatment of COPD.

Methods and Objectives: The Phase 4, multicenter, double-blind, randomized, placebo-controlled, parallel-group Aclidinium Bromide on Long-Term Cardiovascular Safety and COPD Exacerbations in PatieNTs with Moderate to Very Severe COPD (ASCENT COPD) study (NCT01966107) is being conducted at 500 sites in the United States and Canada. The primary objectives are to evaluate the long-term effects of twice-daily aclidinium bromide 400 µg on CV safety and exacerbations in patients with moderate to very severe COPD with a history of cerebrovascular, coronary, or peripheral artery disease, or the presence of ≥2 atherothrombotic risk factors. The primary safety and efficacy variables are time to first major adverse CV event (MACE) (on-study analysis) and rate of moderate to severe COPD exacerbations during the first year of treatment (on-treatment analysis), respectively. The study will be terminated after approximately 122 MACE have occurred.

Citation

Citation: Wise RA, Chapman KR, Scirica BM, et al. Long-term evaluation of the effects of aclidinium bromide on major adverse cardiovascular events and COPD exacerbations in patients with moderate to very severe COPD: Rationale and design of the ascent COPD study. J COPD F. 2018; 5(1): 5-15. doi: http://doi.org/10.15326/jcopdf.5.1.2017.0149

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Sorting Out the Mechanisms of Benefit of High Flow Nasal Cannula in Stable COPD

Posted in: Editorial, Volume 4 | Issue 4

Gerard Criner, MD, FACP, FAACP1

Author Affiliations

  1. Temple University, Philadelphia, Pennsylvania

Address correspondence to:

Dr. Gerard Criner
Email: Gerard.Criner@tuhs.temple.edu

Abstract

This article does not contain an abstract.

Citation

Citation: Criner G. Editorial: Sorting out the mechanisms of benefit of high flow nasal cannula in stable COPD. J COPD F. 2017; 4(4): 259-261. doi: http://doi.org/10.15326/jcopdf.4.4.2017.0176

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The Journal Club: Computed Tomography and COPD

Posted in: Journal Club, Volume 4 | Issue 4

Ron Balkissoon, MD, MSc, DIH, FRCP1

Author Affiliations

  1. Denver, Colorado

Address correspondence to:

Ron Balkissoon, MD
balkissoonr@njhealth.org

Abstract

This article does not contain an abstract.

Citation

Citation: Balkissoon R. The journal club: Computed tomography and COPD. J COPD F. 2017; 4(4): 325-330. doi: http://doi.org/10.15326/jcopdf.4.4.2017.0174

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The COPD Pipeline XXXVI

Posted in: The COPD Pipeline, Volume 4 | Issue 4

Nicholas Gross, MD, PhD1

Author Affiliations

  1. University Medical Research, LLC and St Francis Hospital Hartford, Connecticut

Address correspondence to:

Nicholas Gross, MD, PhD
grossnicholas1@gmail.com

Abstract

This article does not contain an abstract.

 

Citation

Citation: Gross N. The COPD Pipeline XXXVI. J COPD F. 2017; 4(4): 320-324. doi: http://doi.org/10.15326/jcopdf.4.4.2017.0164

Keywords

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Abstract Presentations: COPD10usa 2017

Posted in: COPD9usa, Volume 4 | Issue 4

Barbara P. Yawn, MD, MSc1 Byron Thomashow, MD2

Author Affiliations

  1. Department of Family and Community Health, University of Minnesota School of Medicine, Minneapolis
  2. Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York

Address correspondence to:

Byron Thomashow, MD
Email: bthomashow@copdfoundation.org

Abstract

This article does not contain an abstract.

Citation

Citation: Yawn BP, Thomashow B. Abstract presentations: COPD10usa 2017. J COPD F. 2017; 4(4): 305-319. doi: http://doi.org/10.15326/jcopdf.4.4.2017.0162

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Evaluation and Documentation of Supplemental Oxygen Requirements is Rarely Performed in Patients Hospitalized With COPD

Posted in: Original Research, Volume 4 | Issue 4

Farhan Zaidi, MD1,2 Ryan S. Lee, MD1 Bartosz A. Buchcic, MD1,2 Nina E. Bracken, APN1,2,3 H. Ari Jaffe, MD 1,2 Min Joo, MD, MPH1,2 Valentin Prieto-Centurion, MD1,2 Ai-Yui Tan, MD1,2,3 Jerry A. Krishnan, MD, PhD1,2,3

Author Affiliations

  1. Division of Pulmonary, Critical Care, Sleep and Allergy, Department of Medicine, University of Illinois at Chicago
  2. Jesse Brown Veterans Administration Medical Center, Chicago, Illinois
  3. Population Health Sciences Program, University of Illinois Hospital & Health Sciences System, Chicago

Address correspondence to:

Farhan Zaidi, MD
University of Illinois at Chicago
Mile Square, 3rd floor, Room 3041
1220 S Wood St. (M/C 619)
Chicago, IL 60608
Phone: (312) 413-1960
Email: fzaidi1@uic.edu

Abstract

Rationale: Patients hospitalized with chronic obstructive pulmonary disease (COPD) who require supplemental oxygen (O2) are at increased risk of hospital readmissions. There is a paucity of information regarding quality of evaluation and documentation regarding the need for supplemental O2 in this population. 

Objective: To determine the extent to which evaluation and documentation regarding the need for supplemental O2 occurs prior to hospital discharge in patients with COPD. 

Methods: We conducted a two-center retrospective cohort study of hospitalized adults with a physician diagnosis of COPD.  We reviewed electronic health records to ascertain whether patients underwent evaluation beyond rest oximetry documenting hypoxemia and if there was adequate documentation of supplemental O2 requirements prior to discharge.

Results:  Of 526 patients hospitalized with a primary or secondary discharge diagnosis of COPD, 335 patients (mean age 69 years, 78% with diagnosis of COPD exacerbation) met eligibility criteria. Overall, 1 in 5 (22%, 73/335) hospitalized patients with COPD had an evaluation beyond rest oximetry for supplemental O2 requirements during admission.  Adequate documentation of supplemental O2 requirements occurred in even fewer patients (16%, 54/335). Both evaluation (26% versus 5%, p=0.002) and documentation (19% versus 4%, p=0.001) of supplemental O2 requirements were more common in patients hospitalized for a COPD exacerbation compared to those hospitalized with COPD but without an exacerbation.

Conclusions: Evaluation and documentation of supplemental O2 requirements beyond rest oximetry occur infrequently in patients hospitalized with COPD.

Citation

Citation: Zaidi F, Lee RS, Buchcic BA, et al. Evaluation and documentation of supplemental oxygen requirements is rarely performed in patients hospitalized with COPD. J COPD F. 2017; 4(4): 287-296. doi: http://doi.org/10.15326/jcopdf.4.4.2017.0148

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Differences in Respiratory Symptoms and Lung Structure Between Hispanic and Non-Hispanic White Smokers: A Comparative Study

Posted in: Original Research, Volume 4 | Issue 4

Alejandro A. Diaz, MD, MPH1 Farbod N. Rahaghi, MD, PhD1 Tracy J. Doyle, MD1 Thomas P. Young, BA1 Erick S. Maclean, BS1 Carlos H. Martinez, MD2 Raul San Jose Estepar, PhD3 Stefano Guerra, MD4 Yohannes Tesfaigzi, PhD5 Ivan O. Rosas, MD1 George R. Washko, MD, MSc1 David O. Wilson, MD6

Author Affiliations

  1. Division of Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  2. Division of Pulmonary and Critical Care Medicine, University of Michigan Health System, Ann Arbor
  3. Department of Radiology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  4. Asthma and Airway Disease Research Center and Department of Medicine, University of Arizona, Tucson; and ISGlobal CREAL and Pompeu Fabra University, Barcelona, Spain
  5. Lovelace Respiratory Research Institute, Albuquerque, New Mexico
  6. Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania

Address correspondence to:

Alejandro A. Diaz, MD, MPH
Division of Pulmonary and Critical Care Medicine
Department of Medicine
Brigham and Women’s Hospital
75 Francis Street
Boston, MA 02115
Email: ADiaz6@Partners.org

Abstract

Background: Prior studies have demonstrated that U.S. Hispanic smokers have a lower risk of decline in lung function and chronic obstructive pulmonary disease (COPD) compared with non-Hispanic whites (NHW). This suggests there might be racial-ethnic differences in susceptibility in cigarette smoke-induced respiratory symptoms, lung parenchymal destruction, and airway and vascular disease, as well as in extra-pulmonary manifestations of COPD. Therefore, we aimed to explore respiratory symptoms, lung function, and pulmonary and extra-pulmonary structural changes in Hispanic and NHW smokers.

Methods: We compared respiratory symptoms, lung function, and computed tomography (CT) measures of emphysema-like tissue, airway disease, the branching generation number (BGN) to reach a 2-mm-lumen-diameter airway, and vascular pruning as well as muscle and fat mass between 39 Hispanic and 39 sex-, age- and smoking exposure-matched NHW smokers.

Results: Hispanic smokers had higher odds of dyspnea than NHW after adjustment for COPD and asthma statuses (odds ratio[OR] = 2.96; 95% confidence interval [CI] 1.09-8.04), but no significant differences were found in lung function and CT measurements.

Conclusions: While lung function and CT measures of the lung structure were similar, dyspnea is reported more frequently by Hispanic than matched-NHW smokers.

It seems to be an impossible puzzle but it's easy to solve a Rubik' Cube using a few algorithms.

Citation

Citation: Diaz AA, Rahaghi FN, Doyle TJ, et al. Differences in respiratory symptoms and lung structure between Hispanic and non-Hispanic white smokers: A comparative study. J COPD F. 2017; 4(4): 297-304. doi: http://doi.org/10.15326/jcopdf.4.4.2017.0150

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Effect of Roflumilast on Airway Blood Flow in COPD: A Pilot Study

Posted in: Letters to the Editor, Volume 4 | Issue 4

Eliana S. Mendes, MD1 Patricia Rebolledo, RT1 Lilian Cadet, RT1 Johana Arana, RT1 Andreas Schmid, MD1 Adam Wanner, MD1

Author Affiliations

  1. Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Department of Medicine, University of Miami, Miller School of Medicine, Miami, Florida

Address correspondence to:

Adam Wanner, MD
Email: awanner@miami.edu
Phone: (305) 243-3045

Abstract

This article does not contain an abstract.

Citation

Citation: Mendes ES, Rebolledo P, Cadet L, Arana J, Schmid A, Wanner A. Effect of roflumilast on airway blood flow in COPD: A pilot study. J COPD F. 2017; 4(4): 262-264. doi: http://doi.org/10.15326/jcopdf.4.4.2017.0151

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Impact of Heated Humidified High Flow Air via Nasal Cannula on Respiratory Effort in Patients with Chronic Obstructive Pulmonary Disease

Posted in: Original Research, Volume 4 | Issue 4

Charles W. Atwood, Jr., MD1,2 Sharon Camhi, MD1,2 Kathryn C. Little, MA, RN3 Colleen Paul, RN, PhD1 Hobart Schweikert, MS, RRT1 Nicholas J. Macmillan, BGS, RRT, FAARC4 Thomas L. Miller, PhD5,6

Author Affiliations

  1. Pulmonary Section, Veterans Administration Pittsburgh Healthcare System, Pittsburgh, Pennsylvania
  2. Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
  3. Children’s Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
  4. The MED Group, Inc., Lubbock, Texas
  5. Vapotherm, Inc., Exeter, New Hampshire
  6. Department of Pediatrics, Sydney Kimmel Medical College, Philadelphia, Pennsylvania

Address correspondence to:

Charles W. Atwood, Jr., MD
Associate Professor of Medicine
UPMC Montefiore Hospital - NW628
3459 Fifth Avenue
Pittsburgh, PA 15213
Phone: 412-692-2880
Fax: 412-692-2260
Email: Charles.Atwood@va.gov

Abstract

Background: High flow nasal cannula therapy (HFNC) has been widely adopted for respiratory distress, and evidence suggests that purging dead space of the upper airway improves gas fractions in the lung. This study tests the hypothesis that HFNC with room air could be as effective as low flow oxygen in chronic obstructive pulmonary disease (COPD).

Methods: Thirty-two COPD patients prescribed 1 - 2 L/min of oxygen were studied. The conditions tested consisted of a control (CTRL; no therapy), then in random order HFNC and prescribed low flow oxygen (LFO). HFNC was the highest flow tolerated up to 35 L/min without supplemental oxygen. Arterial blood gases (ABGs), respiratory rate (RR), heart rate (HR) and tidal volume (VT) were measured at the end of each condition.

Results: Arterial oxygen (PaO2) was greater (p < 0.001) for LFO than both HFNC and CTRL (CTRL=57.4±6.1mmHg, HFNC=58.6±8.3mmHg, LFO=72.6±10.2mmHg). HFNC reduced RR by 11% (p<0.05) from CTRL and LFO (CTRL=20.2±3.8br/min, HFNC=17.9±3.3br/min, LFO=20.2±3.7br/min) with no differences in VT. There were no differences between arterial carbon dioxide (PaCO2) (CTRL=45.5±4.9mmHg, HFNC=45.0±5.3mmHg, LFO=46.0±3.9mmHg).

Conclusions: HFNC resulted in a clinically relevant reduction in ventilatory effort with no change in ABG indicating a gas equilibrium effect of purging anatomical dead space.

Clinical Trial Registration: ClinicalTrials.gov ID: NCT00990210

Citation

Citation: Atwood CW Jr., Camhi S, Little KC, et al. Impact of heated humidified high flow air via nasal cannula on respiratory effort in patients with chronic obstructive pulmonary disease. J COPD F. 2017; 4(4): 279-286. doi: http://doi.org/10.15326/jcopdf.4.4.2016.0169

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Recruiting Patients After Hospital Discharge for Acute Exacerbation of COPD: Challenges and Lessons Learned

Posted in: Original Research, Volume 4 | Issue 4

Gary T. Ferguson, MD1 Bonnie Beck, PhD2 Emmanuelle Clerisme-Beaty, MD2 Dacheng Liu, PhD2 Byron M. Thomashow, MD3 Robert A. Wise, MD4 Richard ZuWallack, MD5 Barry J. Make, MD6

Author Affiliations

  1. Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan
  2. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut
  3. College of Physicians and Surgeons, Columbia University, New York, New York
  4. Johns Hopkins University School of Medicine, Baltimore, Maryland
  5. St Francis Hospital Medical Center, Hartford, Connecticut
  6. National Jewish Health, Denver, Colorado

Address correspondence to:

Gary T. Ferguson, MD
Pulmonary Research Institute of Southeast Michigan
29255 West 10 Mile Road, Suite A
Farmington Hills, MI 48336
Phone: 248-478-6561
E-mail: garytferguson@msn.com

Abstract

Background: Hospitalizations for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are associated with increased mortality and decreased quality of life. Replicate hospital discharge studies were initiated to examine efficacy and safety of once-daily tiotropium HandiHaler® versus placebo, in addition to usual care, in patients discharged from the hospital after an AECOPD.

Methods: Both studies were randomized, placebo-controlled, double-blind, parallel-group, multicenter, with inclusion/exclusion criteria providing a diverse COPD patient cohort hospitalized for ≤14 days with AECOPD. Patients received tiotropium or placebo, initiated within 10 days post-discharge. Target recruitment was 604 patients/study and planned duration was event-driven, ending after 631 clinical outcome events across both studies. Inability to reach targeted site numbers and patient recruitment/retention difficulties led to early study termination. Recruitment/retention challenges and protocol amendment impacts were assessed qualitatively to understand the major issues.

Results: Over 18 months, 219 patients were enrolled; 158 were randomized and 61 failed screening. Premature treatment discontinuation occurred in 49(31%) patients, of whom 20(41%) completed health status follow-up. All-cause, 30-day hospital readmission was low (8[5%] patients). A total of 154(98%) patients had a concomitant diagnosis and most took pulmonary medication pre-randomization (143[91%]) and during study treatment (144[92%]). Inclusion/exclusion criteria changes failed to improve recruitment. Recruitment/retention barriers were identified, relating to patient and clinician factors, health care infrastructure, and clinical practices.

Conclusions: Although AECOPD hospitalization is clinically important and incurs high costs, significant challenges exist in studying this population in clinical trials after hospitalization. Studies are needed to evaluate effective management of AECOPD patients at high risk of adverse clinical outcomes.

Citation

Citation: Ferguson GT, Beck B, Clerisme-Beaty E, et al. Recruiting patients after hospital discharge for acute exacerbation of COPD: Challenges and lessons learned. J COPD F. 2017; 4(4): 265-278. doi: http://doi.org/10.15326/jcopdf.4.4.2016.0176

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Erratum

Posted in: Volume 4 | Issue 3, Correction

Sanjay Sethi, MD1 Charles Fogarty, MD2 Nicola A. Hanania, MD3 Fernando J. Martinez, MD, MS4 Stephen Rennard, MD5 Chad Orevillo, MPH6 Patrick Darken, PhD7 Earl St. Rose, MS, MBA8 Shannon Strom, PhD9 Tracy Fischer, PharmD9 Michael Golden9 Sarvajna Dwivedi, PhD10 Colin Reisner, MD 6

Author Affiliations

There are no author affiliations for this article.

Address correspondence to:

There is no correspondance information for this article.

Abstract

This is a correction.

Citation

Citation: Erratum. J COPD F. 2017; 4(3): 258-258. doi: http://doi.org/10.15326/jcopdf.4.3.2016.0158

Keywords

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The Journal Club: COPD Exacerbations

Posted in: Journal Club, Volume 4 | Issue 3

Ron Balkissoon, MD, MSc, DIH, FRCPC1

Author Affiliations

  1. Denver, Colorado

Address correspondence to:

Ron Balkissoon, MD
balkissoonr@njhealth.org

Abstract

This article does not contain an abstract.

Citation

Citation: Balkissoon R. The journal club: COPD exacerbations. J COPD F. 2017; 4(3): 252-257. doi: http://doi.org/10.15326/jcopdf.4.3.2017.0157

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Personalization of Device Therapy – Prime Time for Peak Inspiratory Flow Rate

Posted in: Editorial, Volume 4 | Issue 3

Chee H. Loh, MD1 Jill A. Ohar, MD2

Author Affiliations

  1. Department of Respiratory and Critical Care Medicine, Changi General Hospital, Singapore
  2. Section of Pulmonary, Critical Care, Allergy and Immunology, School of Medicine, Wake Forest University, Winston-Salem, North Carolina

Address correspondence to:

Chee H. Loh, MD
seanchloh@gmail.com

Abstract

This article does not contain an abstract.

Citation

Citation: Loh CH, Ohar JA. Editorial: Personalization of device therapy – prime time for peak inspiratory flow. J COPD F. 2017; 4(3): 172-176. doi: http://doi.org/10.15326/jcopdf.4.3.2017.0155

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The COPD Pipeline XXXV

Posted in: The COPD Pipeline, Volume 4 | Issue 3

Nicholas Gross, MD, PhD1

Author Affiliations

  1. University Medical Research and St Francis Hospital, Hartford Connecticut

Address correspondence to:

Nicholas Gross, MD, PhD
grossnicholas1@gmail.com

Abstract

This article does not contain an abstract

Citation

Citation: Gross N. The COPD Pipeline XXXV. J COPD F. 2017; 4(3): 247-251. doi: http://doi.org/10.15326/jcopdf.4.3.2017.0154

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COPD10: Birmingham,United Kingdom, July 2016

Posted in: COPD9, Birmingham UK, Volume 4 | Issue 3

Robert A. Stockley, MD1

Author Affiliations

  1. Queen Elizabeth Hospital, Birmingham, United Kingdom

Address correspondence to:

Robert A. Stockley, MD
Email: Rob.stockley@uhb.nhs.uk
Phone: +44 121 371 3886

Abstract

This article does not contain an abstract.

Citation

Citation: Stockley RA. Abstract presentations: COPD10, Birmingham, United Kingdom, 2016. J COPD F. 2017; 4(3): 225-246. doi: http://doi.org/10.15326/jcopdf.4.3.2017.0137

Keywords

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The 2017 Update to the COPD Foundation COPD Pocket Consultant Guide

Posted in: Volume 4 | Issue 3, A Statement of the COPD Foundation

Barbara P. Yawn, MD, MSc1 Byron Thomashow, MD2 David M. Mannino, MD3 MeiLan K. Han, MD, MS4 Ravi Kalhan, MD5 Stephen Rennard, MD6 Scott Cerreta7 James D. Crapo, MD8 Robert Wise, MD9

Author Affiliations

  1. Department of Family and Community Health, University of Minnesota School of Medicine, Minneapolis
  2. Department of Medicine, Columbia University College of Physicians and Surgeons, New York, New York
  3. Department of Preventive Medicine and Environmental Health, University of Kentucky, College of Public Health, Lexington
  4. Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, University of Michigan Health System, Ann Arbor
  5. Asthma and COPD Program, Northwestern University Feinberg School of Medicine, Chicago, Illinois
  6. Clinical Discovery Unit, Early Clinical Development, AstraZeneca, Cambridge, United Kingdom and Department of Medicine, University of Nebraska Medical Center, Omaha
  7. COPD Foundation, Washington, D.C.
  8. Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, Colorado
  9. Pulmonary and Critical Care, Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland

Address correspondence to:

Barbara P. Yawn, MD, MSc
1963 112th Circle NE
Blaine, MN 55449
Phone: 507 261 3096
Email: byawn47@gmail.com

Abstract

The COPD Foundation Pocket Consultant Guide (PCG) was first released in 2007 as a practice tool for use at point of service for clinicians, especially primary care clinicians diagnosing and treating patients with chronic obstructive pulmonary disease (COPD). Over the years, the PCG has been supplemented with a mobile app that presents the tool in an online smart phone accessible version that also allows the clinician to enter patient specific data for guidance to next steps of diagnosis or management.

In November 2016, a new update of the PCG was released that incorporates a flow diagram for stepped care that includes the newest recommendation for diagnosis, assessment and treatment; including the broad use of dual bronchodilator therapy and consideration of asthma COPD overlap syndrome (ACOS). The current controversy regarding when to add inhaled corticosteroids (ICSs) is addressed to support clinical decision making.

The PCG comes in 2 versions, one with generic names for COPD drugs available in the United States and one with trade names for those drugs. The update continues to recommend spirometry for those at highest risk, also emphasizing the need to assess symptoms, exacerbation risks and comorbidity before selecting appropriate non-pharmacological as well as pharmacological therapy. The tool is designed to facilitate COPD management in daily practice.

Citation

Citation: Yawn B, Thomashow B, Mannino DM, et al. A statement of the COPD Foundation: The 2017 update to the COPD Foundation COPD Pocket Consultant Guide. J COPD F. 2017; 4(3): 177-185. doi: http://doi.org/10.15326/jcopdf.4.3.2017.0136

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Prevalence of Low Peak Inspiratory Flow Rate at Discharge in Patients Hospitalized for COPD Exacerbation

Posted in: Original Research, Volume 4 | Issue 3

Gulshan Sharma, MD, MPH1 Donald A. Mahler, MD, FCCP2 Valerie M. Mayorga, PharmD3 Kathleen L. Deering, PharmD3 Qing Harshaw, MD, PhD3 Vaidyanathan Ganapathy, PhD4

Author Affiliations

  1. University of Texas Medical Branch, Galveston, Texas
  2. Geisel School of Medicine at Dartmouth, Hanover, New Hampshire and Valley Regional Hospital, Claremont, New Hampshire
  3. EPI-Q, Inc., Oak Brook, Illinois
  4. Sunovion Pharmaceuticals, Inc, Marlborough, Massachusetts

Address correspondence to:

Gulshan Sharma, MD, MPH
Professor and Director, Division of Pulmonary Critical Care & Sleep Medicine
University of Texas Medical Branch
301 University Blvd
Galveston, TX 77555
Telephone: 409-772-2436
Email: gusharma@utmb.edu

Abstract

Background: Low peak inspiratory flow rate (PIFR) (<60 L/min) among patients with chronic obstructive pulmonary disease (COPD) may result in ineffective medication inhalation, leading to poor bronchodilation.

Objective: The objectives of this analysis were to evaluate the prevalence of low PIFR at the time of discharge from a COPD-related hospitalization and to examine the real-world treatment patterns and rehospitalizations by PIFR.

Methods: Patients at 7 sites in the United States were screened for enrollment at hospital discharge. PIFR was measured using the InCheckTM DIAL to simulate resistance of the DISKUS® dry powder inhaler (DPI). An equal number of patients were enrolled into low PIFR (<60 L/min) or normal PIFR (≥60 L/min) cohorts. Demographics, COPD-related clinical characteristics, health status, treatment and rehospitalization data were collected.

Results: Mean PIFR was 71±22.12 L/min among 268 screened patients; 31.7% (n=85) of patients had low PIFR. Among all enrolled patients (n=170), the low PIFR cohort was older (66.2±10.04 years versus 62.1±9.41 years, p=0.006) and more likely to be female (61.2% versus 42.4%, p=0.014). There was an increase in DPI use at discharge, compared with admission, in the low PIFR cohort (62.4% versus 70.6%, p=0.020). The incidences of all-cause rehospitalization up to 180 days were similar between the low and normal PIFR cohorts.

Conclusions: At discharge following hospitalization for an exacerbation of COPD, approximately one-third of patients had a PIFR <60 L/min. More patients with a low PIFR were discharged with a DPI medication compared with use at admission. There was no difference in the rehospitalization rates by PIFR.

Citation

Citation: Sharma G, Mahler DA, Mayorga VM, Deering KL, Harshaw Q, Ganapathy V. Prevalence of low peak inspiratory flow rate at discharge in patients hospitalized for COPD exacerbation.

J COPD F. 2017; 4(3): 217-224. doi: http://doi.org/10.15326/jcopdf.4.3.2017.0183

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Serum Proteins Associated with Emphysema Progression in Severe Alpha-1 Antitrypsin Deficiency

Posted in: Original Research, Volume 4 | Issue 3

Tatsiana Beiko, MD, MSCR1 Michael G. Janech, PhD2 Alexander V. Alekseyenko, PhD3 Carl Atkinson, PhD4 Harvey O. Coxson, PhD5 Jeremy L. Barth, PhD6 Sarah E. Stephenson, PhD1 Carole L. Wilson, PhD1 Lynn M. Schnapp, MD1 Alan Barker, MD7 Mark Brantly, MD8 Robert A. Sandhaus, MD, PhD9 Edwin K. Silverman, MD, PhD10 James K. Stoller, MD, MS11 Bruce Trapnell, MD12 Charlie Strange, MD1 for QUANTUM-1 Investigators *

Author Affiliations

  1. Division of Pulmonary and Critical Care Medicine, Medical University of South Carolina, Charleston
  2. Division of Nephrology, Medical University of South Carolina, Charleston
  3. Biomedical Informatics Center, Departments of Public Health Sciences and Oral Health Sciences, Medical University of South Carolina, Charleston
  4. Department of Microbiology and Immunology, Medical University of South Carolina, Charleston
  5. Centre for Heart Lung Innovation and Department of Radiology, University of British Columbia, Vancouver, Canada
  6. Department of Regenerative Medicine and Cell Biology, Medical University of South Carolina, Charleston
  7. Oregon Health and Science University, Portland
  8. University of Florida Health Science Center, Gainesville
  9. National Jewish Health, Denver, Colorado
  10. Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts
  11. Cleveland Clinic Foundation, Ohio
  12. University of Cincinnati/Cincinnati Children's Hospital Medical Center, Ohio

* QUANTitative lung CT UnMasking emphysema progression in AATD. A list of the QUANTUM investigators is provided in the Acknowledgements section at the end of the article.

Address correspondence to:

Tatsiana Beiko, MD, MSCR
Medical University of South Carolina
96 Jonathan Lucas Street
Charleston, SC 29425
Email: beiko@musc.edu

Abstract

Computed tomography (CT) lung density is an accepted biomarker for emphysema in alpha-1 antitrypsin deficiency (AATD), although concerns for radiation exposure limit its longitudinal use. Serum proteins associated with emphysema, particularly in early disease, may provide additional pathogenic insights. We investigated whether distinct proteomic signatures characterize the presence and progression of emphysema in individuals with severe AATD and normal forced expiratory volume in 1 second (FEV1). QUANTitative lung CT UnMasking emphysema progression in AATD (QUANTUM-1) is a multicenter, prospective 3-year study of 49 adults with severe AATD and FEV1 post-bronchodilator values (Post-BD) ≥ 80% predicted. All participants received chest CT, serial spirometry, and contributed to the serum biobank. Volumetric imaging display and analysis (VIDA) software defined the baseline 15th percentile density (PD15) which was indexed to CT-derived total lung capacity (TLC). We measured 317 proteins using a multiplexed immunoassay (Myriad Discovery MAP® panel) in 31 individuals with a complete dataset. We analyzed associations between initial PD15/TLC, PD15/TLC annual decline, body mass index (BMI), and protein levels using Pearson’s product moment correlation. C-reactive protein (CRP), adipocyte fatty acid-binding protein (AFBP), leptin, and tissue plasminogen activator (tPA) were found to be associated with baseline emphysema and all but leptin were associated with emphysema progression after adjustments were made for age and sex. All 4 proteins were associated with BMI after further adjustment for multiple comparisons was made. The relationship between these proteins and BMI, and further validation of these findings in replicative cohorts require additional studies.

Citation

Citation: Beiko T, Janech MG, Alekseyenko AV, et al; for QUANTUM-1 Investigators. Serum proteins associated with emphysema progression in severe alpha-1 antitrypsin deficiency. J COPD F. 2017; 4(3): 204-216. doi: http://doi.org/10.15326/jcopdf.4.3.2016.0180

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Chronic Pain in People With Chronic Obstructive Pulmonary Disease: Prevalence, Clinical and Psychological Implications

Posted in: Original Research, Volume 4 | Issue 3

Annemarie L. Lee, BPhysio, MPhysio, PhD1,2, Roger S. Goldstein, MBCHB, FRCP(C), FRCP (UK)1,2,3 Dina Brooks, BSc(PT), MSc, PhD1,2

Author Affiliations

  1. Department of Respiratory Medicine, West Park Healthcare Centre, Toronto, Ontario, Canada
  2. Department of Physical Therapy, University of Toronto, Ontario, Canada
  3. Department of Medicine, University of Toronto, Ontario, Canada

Address correspondence to:

Dina Brooks, MSc, PhD
Department of Physical Therapy
University of Toronto, 160-500 University Avenue
Toronto, M5G 1V7
Ontario, Canada
Email: dina.brooks@utoronto.ca
Phone: 00 1 416 978 1739; Fax 00 1 416 243 3747

Abstract

Background: Although pain is a common symptom in chronic obstructive pulmonary disease (COPD), pain characteristics such as frequency, duration and type are unclear. The primary study aim was to identify these pain characteristics in individuals with COPD versus healthy control participants. The secondary aim was to explore the clinical and psychological associations with pain in those with COPD.

Methods: Participants with COPD and age and gender-matched, healthy controls completed questionnaires to elicit pain characteristics. Those with COPD also had assessments of dyspnea, health-related quality of life, psychological associations (anxiety and depression) and physical activity.

Results: Sixty-four participants with COPD (mean [standard deviation (SD)] age 71[10] , forced expiratory volume in 1 second [FEV1] 38% predicted) and 64 control participants (mean [SD] age 67 [13] , FEV1 91% predicted) were included. Chronic pain was more prevalent in individuals with COPD compared to control participants (41% versus 29%, p=0.03). The pain was more prevalent in the chest and upper back (p=0.04). COPD participants with chest or upper back pain had a higher total lung capacity (mean difference 2.0L, 95% confidence interval [CI] 0.6 to 3.0L) compared to COPD participants without pain.Greater dyspnea (p<0.001), more depression (p=0.02) and lower physical activity levels (p=0.03) were also present in people with COPD experiencing pain.

Conclusions: Chronic pain is common in COPD. It is associated with higher dyspnea and depression and lower physical activity.

Citation

Citation: Lee AL, Goldstein RS, Brooks D. Chronic pain in people with chronic obstructive pulmonary disease: Prevalence, clinical and psychological implications. J COPD F. 2017; 4(3): 194-203. doi: http://doi.org/10.15326/jcopdf.4.3.2016.0172

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A Survey of Corticosteroid Dosing for Exacerbations of Chronic Obstructive Pulmonary Disease Requiring Assisted Ventilation

Posted in: Original Research, Volume 4 | Issue 3

Tyree H. Kiser, PharmD1 Jonathan E. Sevransky, MD, MHS2 Jerry A. Krishnan, MD, PhD3 James Tonascia, PhD4 Robert A. Wise, MD5 William Checkley, MD, PhD5 John W. Walsh6† Jamie B. Sullivan, MPH6 Kevin C. Wilson, MD7 Marc Moss, MD8 R. William Vandivier, MD8 for the DECIDE Investigators*

Author Affiliations

  1. Department of Clinical Pharmacy, University of Colorado Anschutz Medical Campus, Aurora
  2. Division of Pulmonary and Critical Care Medicine, Emory University, Atlanta, Georgia
  3. Population Health Sciences Program, University of Illinois Hospital & Health Sciences System, Chicago
  4. Department of Epidemiology and Biostatistics, School of Medicine, Johns Hopkins University, Baltimore, Maryland
  5. Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, Maryland
  6. COPD Foundation, Washington D.C. †Died March 7, 2017
  7. The Pulmonary Center, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts and Official Documents Department, American Thoracic Society, New York, New York
  8. Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado Anschutz Medical Campus, Aurora
  • *DECIDE - DosE of CorticosteroIDs for Exacerbations of COPD

Address correspondence to:

Tyree H. Kiser, PharmD
12850 E Montview Blvd, C238
Pharmacy and Pharmaceutical Sciences Building
Aurora, CO 80045
Email: ty.kiser@ucdenver.edu
Phone: 303-724-2883

Abstract

Background: For over 40 years, systemic corticosteroids have been a mainstay of treatment for patients with exacerbations of chronic obstructive pulmonary disease (COPD). Surprisingly, the optimal dosage of corticosteroids is unknown in critically ill patients requiring assisted ventilation, a group with high morbidity and mortality.

Methods: We surveyed 39 academic physicians within the United States Critical Illness and Injury Trials Group (USCIITG) and the Prevention and Early Treatment of Acute Lung Injury Trials Network (PETAL) to determine the range of corticosteroid dosages used to treat patients with COPD exacerbations requiring assisted ventilation. We also asked if these physicians believe that a clinical trial is needed to determine the optimal dosage of corticosteroids in this population.

Results: Thirty-two physicians (82%) responded to the survey. Usual practice was to start intravenous methylprednisolone at a median dose of 120 mg/day (range 40-500 mg/day). In the context of a clinical trial, 78% of physicians were comfortable initiating methylprednisolone at a dose as low as 40 mg/day. In contrast, physicians were split on the highest acceptable methylprednisolone dose, with 44% comfortable initiating doses as high as 500 mg/day, 44% at 240 mg/day, and 12% at doses less than 240 mg/day. Ninety-four percent of respondents believed that a randomized controlled trial is needed to determine the optimal corticosteroid dose to treat patients with COPD exacerbations requiring assisted ventilation.

Conclusions: These results demonstrate sufficient clinical equipoise to support the conduct of a clinical trial to identify the optimal dose of systemic corticosteroids for patients with COPD exacerbations requiring assisted ventilation.

Citation

Citation: Kiser TH, Sevransky JE, Krishnan JA, et al for the DECIDE investigators. A survey of corticosteroid dosing for exacerbations of chronic obstructive pulmonary disease requiring assisted ventilation. J COPD F. 2017; 4(3): 186-193. doi: http://doi.org/10.15326/jcopdf.4.3.2016.0168

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Remembering John W. Walsh 1949 – 2017

Posted in: Editorial, Volume 4 | Issue 2

James D. Crapo, MD1,2

Author Affiliations

  1. Editor in Chief, Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation
  2. National Jewish Health, Denver, Colorado

Address correspondence to:

James D. Crapo, MD
COPDC@njhealth.org

Abstract

This article does not contain an abstract.

Citation

Citation: Crapo JD. Remembering John Walsh. J COPD F. 2017; 4(2): 81-82. doi: http://doi.org/10.15326/jcopdf.4.2.2017.0147

Keywords

There are no keywords for this article.

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The COPD Pipeline XXXIV

Posted in: The COPD Pipeline, Volume 4 | Issue 2

Nicholas J. Gross MD, PhD1

Author Affiliations

  1. University Medical Research, Saint Francis Hospital and Medical Center, Hartford, Connecticut

Address correspondence to:

Nicholas Gross, MD, PhD
grossnicholas1@gmail.com

Abstract

This article does not contain an abstract.

Citation

Citation: Gross N. The COPD pipeline XXXIV. J COPD F. 2017; 4(2): 159-161. doi: http://doi.org/10.15326/jcopdf.4.2.2017.0138

Keywords

There are no keywords for this article.

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Images in COPD: Bullous Emphysema with Mycetoma

Posted in: Images in COPD, Volume 4 | Issue 2

Simukayi Mutasa, MD1

Author Affiliations

  1. New York Presbyterian Hospital, Columbia University Medical Center, New York, New York

Address correspondence to:

Simukayi Mutasa, MD
New York Presbyterian Hospital
PB 1-301
New York, NY 10032
Email: stm9116@nyp.org

Abstract

This article does not contain an abstract.

Citation

Citation: Mutasa S. Images in COPD: Bullous emphysema with mycetoma. J COPD F. 2017; 4(2): 168-171. doi: http://doi.org/10.15326/jcopdf.4.2.2017.0144

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Journal Club: Inhaled Corticosteroids– Refining Our Understanding of Their Role in Maintenance Treatment for COPD

Posted in: Journal Club, Volume 4 | Issue 2

Ron Balkissoon, MD, MSc, DIH, FRCPC1

Author Affiliations

  1. Denver, Colorado

Address correspondence to:

Ron Balkissoon, MD, MSc, DIH, FRCPC
balkissoonr@njhealth.org

Abstract

This article does not contain an abstract.

Citation

Citation: Balkissoon R. Journal club: Inhaled corticosteroids—refining our understanding of their role in maintenance treatment for COPD. J COPD F. 2017; 4(2): 162-167. doi: http://doi.org/10.15326/jcopdf.4.2.2017.0143

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What’s New with the St George’s Respiratory Questionnaire and Why Do We Care?

Posted in: Editorial, Volume 4 | Issue 2

Megan Hardin, MD, MPH1 Steven I. Rennard, MD2,3

Author Affiliations

  1. Clinical Discovery Unit, Early Clinical Discovery, AstraZeneca, Waltham, Massachusetts
  2. Clinical Discovery Unit, Early Clinical Discovery, AstraZeneca, Cambridge, United Kingdom
  3. University of Nebraska Medical Center, Omaha

Address correspondence to:

Megan Hardin, MD, MPH
Clinical Discovery Unit
Early Clinical Discovery
AstraZeneca
Waltham, MA
email: megan.hardin@astrazeneca.com

Abstract

This article does not contain an abstract.

Citation

Citation: Hardin M, Rennard SI. What’s new with the St George’s Respiratory Questionnaire and why do we care? J COPD F. 2017; 4(2): 83-86. doi: http://doi.org/10.15326/jcopdf.4.2.2017.0139

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Socioeconomic Status as a Determinant of Health Status Treatment Response in COPD Trials

Posted in: Volume 4 | Issue 2, Biomarker Consortium

Paul W. Jones, PhD, FRCP, FERS1 Heather Gelhorn, PhD2 Hilary Wilson, PhD2 Victoria S. Benson, PhD3 Niklas Karlsson, PhD4 Shailendra Menjoge, PhD5 Hana Müllerova, PhD3 Stephen I. Rennard, MD6 Ruth Tal-Singer, PhD7 Debora Merrill, MBA8 Maggie Tabberer, MSc3

Author Affiliations

Paul W. Jones, PhD, FRCP, FERS
Institute for Infection and Immunity
St George’s University of London
London, United Kingdom
Email: pjones@sgul.ac.uk.
Phone: +44 (0)20 8990 9000

Address correspondence to:

  1. Institute for Infection and Immunity, St George’s University of London, United Kingdom
  2. Evidera, Bethesda, Maryland
  3. Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom
  4. Research and Development, AstraZeneca, Gothenburg, Sweden
  5. Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut
  6. Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha
  7. Research and Development, GlaxoSmithKline, King of Prussia, Pennsylvania
  8. COPD Foundation, Washington, D.C.

Abstract

Background: Randomized controlled trials (RCTs) often recruit patients from low and high socioeconomic status (SES) countries, but little is known about the effect of SES on clinical outcomes, particularly patient-centered measures of symptomatic benefit.

Methods: Combined individual chronic obstructive pulmonary disease (COPD) patient data from the placebo and long-acting bronchodilator arms of 17 RCTs (from the COPD Biomarkers Qualification Consortium database) were analyzed. Health status was measured using the St George’s Respiratory Questionnaire (SGRQ) (minimum clinically important difference [MCID]: 4 units). Trials were grouped into short-term (≤12 months) and medium-term (>12 months to 48 months). A participant’s country of residence was categorized into Low/Medium or High SES using World Health Organization criteria.

Results: Data from 19765 individuals (6109 Low/Medium SES) were available. Patients in Low/Medium SES countries had more severe disease at baseline. Improvement in SGRQ score with placebo was ≈2 units greater in Low/Medium than in High SES countries; at its greatest, the improvement from baseline exceeded the MCID in Low/Medium countries. This difference was maintained for at least 1 year. Improvement with bronchodilator was also greater in Low/Medium versus High SES countries; overall there was no evidence that the treatment effect versus placebo was different between countries of different SES status.

Conclusions: Participants in Low/Medium SES countries experienced significantly larger treatment effects, irrespective of treatment group (placebo and bronchodilator). Despite this, COPD patients in Low/Medium SES countries experienced a health status gain from long-acting bronchodilator treatment that is similar to that seen in High SES countries.

Citation

Citation: Jones PW, Gelhorn H, Wilson H, et al. Socioeconomic status as a determinant of health status treatment response in COPD trials. J COPD F. 2017; 4(2): 150-158. doi: http://doi.org/10.15326/jcopdf.4.2.2017.0132

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St George’s Respiratory Questionnaire Score Predicts Outcomes in Patients with COPD: Analysis of Individual Patient Data in the COPD Biomarkers Qualification Consortium Database

Posted in: Volume 4 | Issue 2, Biomarker Consortium

Hana Müllerova, PhD1 Heather Gelhorn, PhD2 Hilary Wilson, PhD2 Victoria S. Benson, PhD1 Niklas Karlsson, PhD3 Shailendra Menjoge, PhD4 Stephen I. Rennard, PhD5,6 Maggie Tabberer, MSc1 Ruth Tal-Singer, PhD7 Debora Merrill, MBA8 Paul W. Jones, PhD, FRCP, FERS1,9

Author Affiliations

  1. Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom
  2. Evidera, Bethesda, Maryland
  3. Research and Development, AstraZeneca, Mölndal, Sweden
  4. Boehringer-Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut
  5. Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha
  6. AstraZeneca, Cambridge, United Kingdom
  7. Respiratory Therapy Area Unit, Research and Development, GlaxoSmithKline, King of Prussia, Pennsylvania
  8. COPD Foundation, Washington, D.C.
  9. Institute for Infection and Immunity, St George’s University of London, United Kingdom

Address correspondence to:

Hana Müllerová, PhD
Respiratory Epidemiology
Research and Development
GlaxoSmithKline
Stockley Park West
1-3 Ironbridge Road
Uxbridge, Middlesex, UB11 1BT
United Kingdom
Email: hana.x.muellerova@gsk.com

Abstract

Background: We aimed to estimate the usefulness of a disease specific health status measure, the St George’s Respiratory Questionnaire (SGRQ), to predict outcomes in patients with chronic obstructive pulmonary disease (COPD).

Methods: Individual patient-data of 12043 patients from long-term randomized clinical trials (2-4 years’ duration) in the COPD Biomarkers Qualification Consortium database were analyzed. The adverse COPD outcomes were: exacerbations of COPD, hospital admissions due to exacerbation and all-cause mortality. Cox proportional hazards regression was used to calculate adjusted hazard ratios (HR) and 95% confidence intervals (CIs) for quartiles of SGRQ scores at baseline and time to first event, and time from first to second event, where appropriate.

Results: The risk of adverse COPD outcomes increased with each increasing quartile of SGRQ score for all time to first event analyses. When comparing the lowest versus the highest quartile, the event risk (HRs [95% CIs]) increased by 40% for exacerbations (1.40 [1.29, 1.51]); 2-fold for hospital admissions (2.01 [1.78, 2.28]) and more than 2-fold for all-cause mortality (2.30 [1.91, 2.78]). For second event analyses in a subset of eligible patients, these trends persisted albeit with reduced risk estimates for exacerbations.

Conclusions: Among patients with COPD, health status measured by a SGRQ score predicted exacerbations of COPD, hospital admissions due to exacerbations and their recurrence and death after adjustment. These data support the rationale for a health status measure use as a drug development tool and suggest that a health status measure may also have a role in risk assessment for COPD patients in routine medical care.

Citation

Citation: Müllerova H, Gelhorn H, Wilson H, et al.St George’s Respiratory Questionnaire score predicts outcomes in patients with COPD: Analysis of individual patient data in the COPD Biomarkers Qualification Consortium Database. J COPD F. 2017; 4(2): 141-149. doi: http://doi.org/10.15326/jcopdf.4.2.2017.0131

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Baseline Severity as Predictor of Change in St George’s Respiratory Questionnaire Scores in Trials of Long-acting Bronchodilators with COPD Patients

Posted in: Volume 4 | Issue 2, Biomarker Consortium

Paul W. Jones, PhD, FRCP, FERS1,2 Heather Gelhorn, PhD3 Niklas Karlsson, PhD4 Shailendra Menjoge, PhD5 Hana Müllerova, PhD2 Stephen I. Rennard, MD6,7 Ruth Tal-Singer, PhD8 Hilary Wilson, PhD3 Debora Merrill, MBA9 Maggie Tabberer, MSc2

Author Affiliations

  1. Institute of Infection and Immunity, St George’s University of London, United Kingdom
  2. Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom
  3. Evidera, Bethesda, Maryland
  4. Research and Development, AstraZeneca, Gothenburg, Sweden
  5. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut
  6. Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha
  7. Research and Development, AstraZeneca, Cambridge, United Kingdom
  8. Research and Development, GlaxoSmithKline, King of Prussia, Pennsylvania
  9. COPD Foundation, Washington, D.C.

Address correspondence to:

Paul W. Jones, PhD, FRCP, FERS
Institute of Infection and Immunity
St George’s University of London
London, United Kingdom
Email: pjones@sgul.ac.uk
Phone: +44 (0)20 8990 9000

Abstract

Background: In trials oflong-acting bronchodilators, health status is an important trial outcome, however the influence of baseline severity on response measured by St George’s Respiratory Questionnaire (SGRQ) is not known. We have compared SGRQ changes between patients with chronic obstructive pulmonary disease (COPD) of mild-moderate severity or dyspnea (Global initiative for chronic Obstructive Lung disease [GOLD] grades 1 and 2; modified Medical Research Council [mMRC] grades 1 and 2) to those with severe-very severe severity or dyspnea (GOLD grades 3 and 4; mMRC grades 3 and 4).

Methods: Combined individual patient data from the COPD Biomarkers Qualification Consortium database (trials of long-acting bronchodilators) were used comprising of patients from short-term (≤1-year duration; n=10802) and medium-term (2-4 years’ duration; n=8963) studies. A repeated measures analysis of variance (ANOVA) was used to determine the effects of baseline severity (GOLD/mMRC) on SGRQ response to treatment. All treatment arms were combined.

Results: In short-term studies, milder patients showed a greater response than those with more severe disease in terms of GOLD grade (partial Eta2 = 0.03, p < 0.0001) and mMRC grade (partial Eta2 = 0.05, p < 0.0001). Similar results were seen in the medium-term studies (partial Eta2 = 0.02, p < 0.0001; mMRC: partial Eta2 = 0.05, p < 0.0001,).

Conclusions: Patients with less severe airflow limitation and less severe dyspnea showed larger improvements in SGRQ score than more severely obstructed or dyspneic patients. Although these severity influences are small (2%-5% of the variance in SGRQ score), they do suggest that pre-specified separate analyses are warranted to test for differences in response, based on baseline severity.

Citation

Citation: Jones PW, Gelhorn H, Karlsson N, et al. Baseline severity as predictor of change in St George’s Respiratory Questionnaire scores in trials of long-acting bronchodilators with COPD patients. J COPD F. 2017; 4(2): 132-140. doi: http://doi.org/10.15326/jcopdf.4.2.2017.0129

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Responder Analyses for Treatment Effects in COPD Using the St George’s Respiratory Questionnaire

Posted in: Volume 4 | Issue 2, Biomarker Consortium

Paul W. Jones, PhD, FRCP, FERS1,2 Heather Gelhorn, PhD3 Hilary Wilson, PhD3 Niklas Karlsson, PhD4 Shailendra Menjoge, PhD5 Hana Müllerova, PhD2 Stephen I. Rennard, MD6,7 Ruth Tal-Singer, PhD8 Debora Merrill, MBA9 Maggie Tabberer, MSc2

Author Affiliations

  1. Division of Clinical Science and Institute of Infection and Immunity, St George’s University of London, United Kingdom
  2. Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom
  3. Evidera, Bethesda, Maryland
  4. Research and Development, AstraZeneca, Gothenburg, Sweden
  5. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut
  6. Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha
  7. Research and Development, AstraZeneca, Cambridge, United Kingdom
  8. Research and Development, GlaxoSmithKline, Upper Merion, Pennsylvania
  9. COPD Foundation, Washington, D.C.

Address correspondence to:

Paul W. Jones, PhD, FRCP, FERS
St George’s University of London
London, United Kingdom
Email: pjones@sgul.ac.uk.
Phone: +44 (0)20 8990 9000

Abstract

Background: Patient-reported outcomes data in clinical trials are usually reported as mean values, interpreted in comparison to a minimum clinically important difference (MCID) and ignoring the possibility of a sizable proportion of patients experiencing a worthwhile benefit when the majority did not. This analysis tested the reliability of calculated responder rates (from chronic obstructive pulmonary disease [COPD] patients) with the St George’s Respiratory Questionnaire (SGRQ) using a range of responder cut-points above and below the MCID (4 units).

Methods: Individual patient data (i.e., data from long-acting bronchodilator [LAB] and inhaled corticosteroids [ICS]/long-acting beta2-agonist [LABA] randomized clinical studies) in the COPD Biomarker Qualification Consortium database were used: short-term (≤1-year duration; 14,814 patients,) and medium-term (2-4 years; 12,043 patients). Responder rates versus placebo across SGRQ score change thresholds ranging from -1.5 to -8.0 were tested; differences were expressed as the odds ratio (OR) of a patient exceeding the threshold versus no change or deterioration.

Results: The ORs measuring benefit of active treatment were similar across thresholds in short-term studies (LAB, ORs 1.40-1.42; LABA/ICS, 1.50-1.56) and medium-term LAB studies (ORs 1.34-1.43), whereas ORs in medium-term studies with LABA/ICS intervention showed a trend for higher response rates at higher values of threshold cut-points (1.64-1.79). In short-term studies, different thresholds had little effect on the OR between active drugs versus a trend for lower ORs with lower thresholds in medium-term studies.

Conclusions: The OR for a treatment effect compared with placebo appears consistent across a range of responder cut-points. In medium-term trials, the treatment difference between active drugs suggests that use of a lower threshold would not increase the odds of observing a measured treatment difference.

Citation

Citation: Jones PW, Gelhorn H, Wilson H, et al. Responder analyses for treatment effects in COPD using the St George’s Respiratory Questionnaire. J COPD F. 2017; 4(2): 124-131. doi: http://doi.org/10.15326/jcopdf.4.2.2017.0130

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The COPD Biomarkers Qualification Consortium Database: Baseline Characteristics of the St George’s Respiratory Questionnaire Dataset

Posted in: Volume 4 | Issue 2, Biomarker Consortium

Maggie Tabberer, MSc1 Victoria S. Benson, PhD1 Heather Gelhorn, PhD2 Hilary Wilson, PhD2 Niklas Karlsson, PhD3 Hana Müllerova, PhD1 Shailendra Menjoge, PhD4 Stephen I. Rennard, MD5,6 Ruth Tal-Singer, PhD7 Debora Merrill, MBA8 Paul W. Jones, PhD, FRCP, FERS1,9 for the COPD Biomarkers Qualification Consortium

Author Affiliations

  1. Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom
  2. Evidera, Bethesda, Maryland
  3. Research and Development, AstraZeneca, Gothenburg, Sweden
  4. Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut
  5. Division of Pulmonary, Critical Care, Sleep and Allergy, Nebraska Medical Center, Omaha
  6. Research and Development, AstraZeneca, Cambridge, United Kingdom
  7. Research and Development, GlaxoSmithKline, Upper Merion, Pennsylvania
  8. COPD Foundation, Washington, D.C.
  9. Division of Clinical Science, St George’s University of London, United Kingdom

Address correspondence to:

Maggie Tabberer
Research & Development
GlaxoSmithKline
Uxbridge, United Kingdom
Phone:+44 20 8990 2041
Email: margaret.x.tabberer@gsk.com

Abstract

The COPD Biomarkers Qualification Consortium (CBQC) is a public-private partnership formed in 2010 with a goal of qualifying biomarkers and clinical assessment tools for use in clinical or nonclinical decision-making and particularly within the regulatory context.

The St George’s Respiratory Questionnaire (SGRQ) is a measure of health-related quality of life widely used in clinical research. The aim of the CBQC working group on SGRQ was to construct an individual patient level database of clinical trial data that included the SGRQ, to use this to confirm the reliability and validity of the SGRQ as an outcome measure of health status, and investigate its use as a predictor of future events (exacerbations and mortality). This manuscript describes the formulation of the CBQC database and presents the baseline demographic and clinical characteristics of the integrated SGRQ database overall, and by study type (short-term [≤1 year], medium-term [2-4 years] and observational studies).

Distribution of baseline SGRQ scores varied little by demographic determinants except for income region in the observational data set (low-middle income countries +10 units compared with high income, p<0.0001) and this observation held across studies. SGRQ scores increased with increasing modified Medical Research Council dyspnea scores (mean differences ranged 6.9-17.9 units) and with increasing airflow limitations (Global initiative for chronic Obstructive Lung Disease grades 1 to 4; differences ranged 4.5-16.1 units), consistent across study types.

As a method of cross-sectional comparison, the SGRQ appears to be relatively free of bias from demographic factors although care should be taken when making cross sectional comparisons of scores between patients in countries at different levels of socio-economic development/

Citation

Citation: Tabberer M, Benson VS, Gelhorn H, et al. The COPD Biomarkers Qualification Consortium database: Baseline characteristics of the St George’s Respiratory Questionnaire dataset. J COPD F. 2017; 4(2): 112-123. doi: http://doi.org/10.15326/jcopdf.4.2.2017.0128

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The COPD Biomarkers Qualification Consortium St George’s Respiratory Questionnaire Manuscripts: Output of a Consortium to Advance Drug Development

Posted in: Volume 4 | Issue 2, Biomarker Consortium

Maggie Tabberer, MSc1* Paul W. Jones, PhD, FRCP, FERS1,2*

Author Affiliations

*St Georges’ Respiratory Questionnaire Working Group Chairs for the COPD Biomarkers Qualification Consortium

  1. Research and Development, GlaxoSmithKline, Uxbridge, United Kingdom
  2. Division of Clinical Science, Institute for Infection and Immunity, St George’s University of London, United Kingdom

Address correspondence to:

Paul W. Jones, PhD
St George’s University of London
Email: pjones@sgul.ac.uk
Phone: 44 (0)20 8990 9000

Abstract

This article does not contain an abstract.

Citation

Citation: Tabberer M, Jones PW. The COPD Biomarkers Qualification Consortium St George’s Respiratory Questionnaire manuscripts: Output of a consortium to advance drug development. J COPD F. 2017; 4(2): 109-111. doi: http://doi.org/10.15326/jcopdf.4.2.2017.0127

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Subtyping Chronic Obstructive Pulmonary Disease Using Peripheral Blood Proteomics

Posted in: Original Research, Volume 4 | Issue 2

Sara Zarei, PhD1,2 Ali Mirtar, PhD3 Jarrett D. Morrow, PhD1 Peter J. Castaldi, MD1 Paula Belloni, PhD4 Craig P. Hersh, MD, MPH1

Author Affiliations

  1. Channing Division of Network Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts
  2. San Juan Bautista School of Medicine, Caguas, Puerto Rico
  3. University of California, San Diego
  4. Genentech, San Francisco, California

Address correspondence to:

Craig P. Hersh, MD, MPH
Channing Division of Network Medicine
Brigham and Women’s Hospital
181 Longwood Ave
Boston, MA 02115
Phone: 617-525-0729
Email: craig.hersh@channing.harvard.edu

Abstract

Chronic obstructive pulmonary disease (COPD) is a heterogeneous disorder. COPD patients may have different clinical features, imaging characteristics and natural history. Multiple studies have investigated heterogeneity using statistical methods such as unsupervised clustering to define different subgroups of COPD based largely on clinical phenotypes. Some studies have performed clustering using genetic data or limited numbers of blood biomarkers. Our primary goal was to use proteomic data to find subtypes of COPD within clinically similar individuals. In the Treatment of Emphysema with a gamma-Selective Retinoid Agonist (TESRA) study, multiplex biomarker panels were run in serum samples collected prior to randomization. After implementing an algorithm to minimize missing values, the dataset included 396 COPD individuals and 87 biomarkers. Using hierarchical clustering, we identified 3 COPD subgroups, containing 267 (67.4%), 104 (26.3%), and 25 (6.3%) individuals, respectively. The third cluster had less emphysema on quantitative analysis of chest computed tomography scans (p=0.03) and worse disease-related quality of life based on the St. George’s Respiratory Questionnaire (total score cluster 1: 45.6, cluster 2: 45.4, cluster 3: 56.6; p=0.01), despite similar levels of lung function impairment (forced expiratory volume in 1 second (49.2%, 49.2%, 48.2 % predicted, respectively). Enrichment analysis showed the biomarkers distinguishing cluster 3 mapped to platelet alpha granule and cell chemotaxis pathways. Thus, we identified a subgroup which has less emphysema but may have greater inflammation, which could be potentially targeted with anti-inflammatory therapies.

Citation

Citation: Zarei S, Mirtar A, Morrow JD, Castaldi PJ, Belloni P, Hersh CP. Subtyping chronic obstructive pulmonary disease using peripheral blood proteomics. J COPD F. 2017; 4(2): 97-108. doi: http://doi.org/10.15326/jcopdf.4.2.2016.0147

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Asthma and Chronic Obstructive Pulmonary Disease Overlap: The Effect of Definitions on Measures of Burden

Posted in: Original Research, Volume 4 | Issue 2

David M. Mannino, MD1 Wen Qi Gan, MD, PhD1 Keele Wurst, PhD, MS2 Kourtney J. Davis, PhD, MS2

Author Affiliations

  1. Department of Preventive Medicine and Environmental Health, College of Public Health, University of Kentucky, Lexington
  2. Real World Evidence and Epidemiology, Research and Development, GlaxoSmithKline Collegeville, Pennsylvania

Address correspondence to:

David M. Mannino, MD
Department of Preventive Medicine and Environmental Health
College of Public Health
University of Kentucky
111 Washington Ave
Lexington, KY 40536
Phone: (859) 218-2099
E-mail: dmannino@uky.edu

Abstract

Background: Although the overlap between asthma and COPD has been recognized for years this overlap has only recently been given a name, asthma-COPD overlap syndrome (ACOS), and better defined. Different definitions of the component diseases can affect prevalence and outcome measures of ACOS.

Methods: We used data from the National Health and Nutrition Examination Survey (NHANES) from 2007-2012 to determine the population estimates of ACOS in U.S. adults using 2 different definitions of ACOS (ACOS1= self-reported COPD and current asthma; ACOS2 = spirometric-confirmed COPD [pre-bronchodilator FEV1/FVC < 70%] and current asthma) and to describe variation in other factors, such as lung function impairment and health care utilization, by ACOS definitions.

Results: Among U.S. adults aged 20 and older, 1.6% had ACOS1, and 1.9% had ACOS2. Both case definitions were similar with regard to symptoms and impairment of lung function. ACOS1 individuals were more likely to have one or more overnight hospital stays relative to those with neither asthma nor COPD, (odds ratio [OR] 3.4, 95% confidence interval [CI] 2.5, 4.6) than ACOS2 (OR 1.6, 95% CI 0.9, 2.9).

Conclusions: Different definitions of ACOS in population-based studies affect both estimates of disease prevalence and outcomes related to the disease. These definitions need to be carefully considered in the design of epidemiologic studies and clinical trials.

Citation

Citation: Mannino DM, Gan WQ, Wurst K, Davis KJ.Asthma and chronic obstructive pulmonary disease overlap: The effect of definitions on measures of burden. J COPD F. 2017; 4(2): 87-96. doi: http://doi.org/10.15326/jcopdf.4.2.2016.0159

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The COPD Pipeline XXXIII

Posted in: The COPD Pipeline, Volume 4 | Issue 1

Nicholas J. Gross MD, PhD1

Author Affiliations

  1. University Medical Research, Saint Francis Hospital and Medical Center, Hartford, Connecticut

Address correspondence to:

Nicholas Gross, MD, PhD
grossnicholas1@gmail.com

Abstract

This article does not contain an abstract.

Citation

Citation: Gross N. The COPD pipeline XXXIII. J COPD F. 2017; 4(1): 65-70. doi: http://doi.org/10.15326/jcopdf.4.1.2016.0178

Keywords

There are no keywords for this article.

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Images in COPD: Combined Pulmonary Emphysema and Fibrosis with Pulmonary Hypertension

Posted in: Images in COPD, Volume 4 | Issue 1

Firdaus A. Mohamed Hoesein, MD, PhD1 Mareye Voortman, MD2 Johanna M. Kwakkel-van Erp, MD, PhD2 Bart Luijk, MD, PhD1 Pim A. de Jong, MD, PhD2

Author Affiliations

  1. Department of Radiology University, Medical Center Utrecht, The Netherlands
  2. Department of Respiratory Medicine, University Medical Center Utrecht, Utrecht, The Netherlands

Address correspondence to:

Firdaus A. Mohamed Hoesein, MD, PhD
Department of Radiology
University Medical Center Utrecht
P.O. Box 85500, HP E01.132
3508GA Utrecht, The Netherlands
E-mail: fmohamedhoesein@gmail.com
Phone: +31 88 75554722

Abstract

This article does not contain an abstract.

Citation

Citation: Mohamed Hoesein FA, Voortman M, Kwakkel-van Erp JM, Luijk B, de Jong PA. Images in COPD: Combined pulmonary emphysema and fibrosis with pulmonary hypertension. J COPD F. 2017; 4(1): 76-80. doi: http://doi.org/10.15326/jcopdf.4.1.2016.0171

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Journal Club: COPD and Oxygen Therapy

Posted in: Journal Club, Volume 4 | Issue 1

Ron Balkissoon, MD, MSc, DIH, FRCPC1

Author Affiliations

  1. Denver, Colorado

Address correspondence to:

Ron Balkissoon, MD, MSc, DIH, FRCPC
balkissoonr@njhealth.org

Abstract

This article does not contain an abstract.

Citation

Citation: Balkissoon R. Journal club: Oxygen therapy. J COPD F. 2017; 4(1): 71-75. doi: http://doi.org/10.15326/jcopdf.4.1.2016.0181

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Nebulized Long-Acting Beta2-Agonists: More Than Just Bridging Gaps in the Management of Symptomatic COPD

Posted in: Editorial, Volume 4 | Issue 1

Daniel A. Gerardi, MD1 Nicholas J. Gross, MD2

Author Affiliations

  1. Department of Pulmonary Medicine, Saint Francis Hospital and Medical Center, Hartford, Connecticut and The University of Connecticut School of Medicine, Farmington
  2. University Medical Research, Saint Francis Hospital and Medical Center, Hartford, Connecticut and The University of Connecticut School of Medicine, Farmington

Address correspondence to:

Daniel A. Gerardi, MD
dgerardi@stfranciscare.org

Abstract

This article does not contain an abstract.

Citation

Citation: Gerardi DA, Gross NJ. Nebulized long-acting beta2-agonists: More than just bridging gaps in the management of symptomatic COPD. J COPD F. 2017; 4(1): 1-3. doi: http://doi.org/10.15326/jcopdf.4.1.2016.0175

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Benefits Among Patients with Alpha-1 Antitrypsin Deficiency Enrolled in a Disease Management and Prevention Program

Posted in: Original Research, Volume 4 | Issue 1

Jordan T. Perkins, MPH1 Radmila Choate, MPH1 David M. Mannino, MD1,2 Steven R. Browning, PhD, MSPH2 Robert A. Sandhaus, MD, PhD3

Author Affiliations

  1. Department of Preventive Medicine and Environmental Health, University of Kentucky College of Public Health, Lexington
  2. Department of Epidemiology, University of Kentucky College of Public Health, Lexington
  3. Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, Colorado

Address correspondence to:

David M. Mannino, MD
Department of Preventive Medicine and Environmental Health
University of Kentucky College of Public Health
111 Washington Avenue
Lexington, KY 40536
Phone: 859 218 2099
E-mail: dmannino@uky.edu

Abstract

Rationale: Alpha-1 antitrypsin deficiency (AATD) is characterized by decreased circulating levels or activity of the serum protein, alpha-1 antitrypsin, which increases risk for chronic lung or liver injury and may lead to diseases such as chronic obstructive pulmonary disease (COPD). Currently there is no cure for AATD, and it is largely controlled through disease management and augmentation therapy. This study was designed to describe characteristics of patients enrolled in a disease management and prevention program.

Methods: Data from questionnaires administered by AlphaNet were obtained on 4747 AATD patients and included demographic information, medical history, lifestyle choices, and adherence to the Alpha-1 Disease Management and Prevention Program (ADMAPP). A total of 1221 participants (25.72%) had missing adherence information and were excluded, leaving a final study population of 3526. Questionnaire answer dates ranged from May 29, 2008 to February 14, 2015. Logistic regression was used to adjust for demographic factors and comorbidities, comparing the populations stratified by adherence to ADMAPP.

Results: After adjustment for age, sex, race, Charlson Comorbidity Index, and income level, individuals who self-reported any adherence to ADMAPP were more likely to feel informed about their condition (odds ratio[OR]adj 4.95, 95% confidence interval[CI][3.24, 7.57]), and be taking preventive measures, such as smoking cessation (ORadj 0.47, 95% CI [0.31, 0.70]), appropriate immunizations, and self-reported exercise (ORadj 2.07, 95% CI [1.74, 2.47]).

Conclusions: This study suggests that ADMAPP may be a useful tool for informing and improving preventive measures taken by individuals with AATD. Future studies are needed to clarify the observed associations and study additional outcomes.

Citation

Citation: Perkins JT, Choate R, Mannino DM, Browning SR, Sandhaus RA. Benefits among patients with alpha-1 antitrypsin deficiency enrolled in a disease management and prevention program. J COPD F. 2017; 4(1): 56-64. doi: http://doi.org/10.15326/jcopdf.4.1.2016.0161

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GOLD Stage and Treatment in COPD: A 500 Patient Point Prevalence Study

Posted in: Original Research, Volume 4 | Issue 1

Katherine A. Safka, MD, FRCP(C)1 Joshua Wald, MD, FRCP(C)1 Hongyu Wang, MD, PhD1 Luke McIvor,1 Andrew McIvor, MD, MSc, FRCP(C)1

Author Affiliations

  1. Firestone Institute for Respiratory Health, McMaster University, Hamilton, Ontario, Canada

Address correspondence to:

R.A. McIvor, MD
T2127 FIRH, St. Joseph’s Healthcare
50 Charlton Avenue East
McMaster University
Hamilton, Ontario, Canada
Email: amcivor@stjosham.on.ca
Phone: (905)522-1155 Ext 34330

Abstract

Background and Objective: The Global initiative for chronic Obstructive Lung Disease (GOLD) guidelines recommend using a combination of spirometry, symptoms and exacerbation history to classify patients into 4 categories (A, B, C, D) to guide treatment decisions along with a stepwise increase in therapy. Our objectives were to identify the GOLD stage of patients in respiratory outpatient clinics and assess how treatment compares to guideline recommendations.

Methods: This was a point prevalence study using a convenience sample of 500 patients with chronic obstructive pulmonary disease (COPD) from a single tertiary care outpatient respiratory clinic.

Results: Patients’ GOLD classification was determined based on symptoms (modified Medical Research Council [mMRC] dyspnea scale, COPD Assessment Test [CAT]), spirometry and self-reported exacerbation history. A total of 8.2% of patients were in the GOLD group A, 28.3% in group B, 4.2% in group C and 59.2% in group D.

Conclusions: In this 500 patient point prevalence study we report a low proportion of patients in GOLD group C and a high level of inhaled corticosteroids (ICS)/ long-acting beta2-agonist (LABA) and triple therapy use throughout all GOLD categories.

Clinical Implications: The GOLD guidelines have attempted to provide direction to practitioners by grouping patients into 4 groups based on symptoms and exacerbations however, the low prevalence of GOLD group C may indicate that not all of these groupings are clinically relevant. Future research is needed to better identify clinically relevant phenotypes that predict benefit from ICS and methods to promote guideline concordant management in COPD.

Citation

Citation: Safka KA, Wald J, Wang H, McIvor L, McIvor A. GOLD stage and treatment in COPD: A 500 patient point prevalence study. J COPD F. 2017; 4(1): 45-55. doi: http://doi.org/10.15326/jcopdf.4.1.2016.0126

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Progressing the Progress Note for COPD

Posted in: Letters to the Editor, Volume 4 | Issue 1

Deborah A. Goss, MD1

Author Affiliations

  1. Hackensack University Medical Center, Hackensack, New Jersey

Address correspondence to:

Deborah A. Goss, MD
Email: gossda0325@gmail.com

Abstract

This article does not contain an abstract.

Citation

Citation: Goss DA. Progressing the progress note for COPD. J COPD F. 2017; 4(1): 4-6. doi: http://doi.org/10.15326/jcopdf.4.1.2016.0155

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The Effect of Alpha-1 Proteinase Inhibitor on Biomarkers of Elastin Degradation in Alpha-1 Antitrypsin Deficiency: An Analysis of the RAPID/RAPID Extension Trials

Posted in: Original Research, Volume 4 | Issue 1

Shuren Ma, PhD1 Yong Y. Lin, PhD1 Jerome O. Cantor, MD1 Kenneth R. Chapman, MD2 Robert A. Sandhaus, MD3 Michael Fries, PhD4 Jonathan M. Edelman, MD4 N. Gerard McElvaney, MD5 Gerard M. Turino, MD1

Author Affiliations

  1. James P. Mara Center for Lung Disease at Mt. Sinai, Department of Medicine, St. Luke’s-Roosevelt Hospital, New York, New York
  2. Asthma and Airway Centre, University Health Network, Toronto Western Hospital, Toronto, Ontario, Canada
  3. Division of Pulmonary, Critical Care and Sleep Medicine, National Jewish Health, Denver, Colorado
  4. Clinical Strategy and Development, CSL Behring, King of Prussia, Pennsylvania
  5. Department of Respiratory Medicine, Beaumont Hospital, Royal College of Surgeons in Ireland, Dublin, Ireland

Address correspondence to:

Gerard M. Turino, MD
Professor of Medicine
Division of Pulmonary, Critical Care and Sleep Medicine
Mount Sinai Roosevelt and Mount Sinai St. Luke's,
New York, NY
Phone: (212) 523-5919 / (212) 523-8672
Email: gmt1@columbia.edu

Abstract

The RAPID (NCT00261833; N=180) and RAPID Extension (NCT00670007; N=140) trials demonstrated significantly reduced lung density decline in patients with alpha-1 antitrypsin deficiency (AATD) receiving alpha-1 proteinase inhibitor (A1PI) versus placebo. Desmosine and isodesmosine (DES/IDES) are unique crosslinkers of mature elastin fibers and are utilized as measures of elastin degradation. The aim of this post-hoc study was to determine the effect of A1PI therapy on DES/IDES levels in patients from RAPID/RAPID Extension.

Plasma levels of DES/IDES were measured using high-performance liquid chromatography and tandem mass spectrometry. Correlation between changes in DES/IDES levels and computed tomography (CT) lung density decline was assessed.

Analysis showed that DES/IDES levels were significantly reduced versus baseline in patients receiving A1PI at all time points, from month 3 through month 48. A significant increase from baseline in DES/IDES was observed with placebo at month 24 (n=54; 0.016; p=0.018). DES/IDES change from baseline was significantly different with A1PI versus placebo at months 3 (-0.021; 95% confidence interval [CI] -0.037, 0.004; p=0.026), 12 (-0.040; 95% CI -0.055, 0.025; p<0.001), and 24 (-0.052; 95% CI -0.070, 0.034; p<0.001). Placebo patients started A1PI therapy at month 24 and showed significant reductions in plasma DES/IDES at months 36 (p<0.001) and 48 (p<0.001). Reduced elastin degradation was associated with slower lung density decline (p=0.005), correlating a chemical index of therapy with an anatomical index by CT.

In conclusion, A1PI therapy reduced elastin degradation, including pulmonary elastin, in patients with AATD. These data support using DES/IDES levels as biomarkers to monitor emphysema progression and treatment response.

Citation

Citation: Ma S, Lin YY, Cantor JO, et al. The effect of alpha-1 proteinase inhibitor on biomarkers of elastin degradation in alpha-1 antitrypsin deficiency: An analysis of the RAPID/RAPID Extension trials. J COPD F. 2017; 4(1): 34-44. doi: http://doi.org/10.15326/jcopdf.4.1.2016.0156

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Efficacy of Formoterol Fumarate Delivered by Metered Dose Inhaler Using Co-Suspension™ Delivery Technology Versus Foradil® Aerolizer® in Moderate-To-Severe COPD: A Randomized, Dose-Ranging Study

Posted in: Original Research, Volume 4 | Issue 1

Sanjay Sethi, MD1 Charles Fogarty, MD2 Nicola A. Hanania, MD3 Fernando J. Martinez, MD, MS4 Stephen Rennard, MD5 Chad Orevillo, MPH6 Patrick Darken, PhD7 Earl St. Rose, MS, MBA8 Shannon Strom, PhD9 Tracy Fischer, PharmD9 Michael Golden9 Sarvajna Dwivedi, PhD10 Colin Reisner, MD 6

Author Affiliations

  1. Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo
  2. Spartanburg Medical Research, Spartanburg, South Carolina
  3. Section of Pulmonary and Critical Care Medicine, Baylor College of Medicine, Houston, Texas
  4. Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York, New York
  5. Clinical Discovery Unit, AstraZeneca, Cambridge, Cambridgeshire, United Kingdom
  6. Clinical Development, Pearl Therapeutics Inc., Morristown, New Jersey
  7. Biostatistics, Pearl Therapeutics Inc., Morristown, New Jersey
  8. Clinical Operations, Pearl Therapeutics Inc., Morristown, New Jersey
  9. Regulatory Affairs, Pearl Therapeutics Inc., Durham, North Carolina
  10. Pearl Therapeutics Inc., Redwood City, California

Address correspondence to:

Sanjay Sethi, MD
Phone: 001 716 862 7875
Email: ssethi@buffalo.edu

Abstract

Background: Co-Suspension™ Delivery Technology offers a novel pharmaceutical platform for inhaled drug therapy. This randomized, double-blind, placebo-controlled, single-dose study (NCT01349868) evaluated the efficacy of a range of doses for formoterol fumarate (FF) delivered using Co-Suspension delivery technology via a pressurized metered dose inhaler (MDI) versus placebo in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). Secondary objectives included determination of non-inferior efficacy and systemic exposure compared with open-label Foradil® 12 μg (Foradil® Aerolizer®; formoterol fumarate dry powder inhaler).

Methods: Patients received each of the 6 study treatments (FF MDI [7.2, 9.6 and 19.2μg], placebo MDI and open-label Foradil® [12 and 24µg]), separated by 3–10 days. Spirometry was performed 60 and 30 minutes prior to and at regular intervals up to 12 hours post-administration of study drug. The primary outcome measure was the change in forced expiratory volume in 1 second (FEV1) area under the curve between 0 and 12 hours (AUC0-12) relative to test day baseline.

Results: A total of 50 patients were randomized to study treatment sequences. All doses of FF MDI demonstrated superiority to placebo (p<0.0001) and non-inferiority to Foradil® 12μg, on bronchodilator outcome measures. No serious adverse events were reported during the study.

Conclusions: This study demonstrates non-inferiority of bronchodilator response and bioequivalent exposure of FF MDI 9.6μg to Foradil® 12μg, with both agents exhibiting a similar safety profile in patients with moderate-to-severe COPD. This study supports the selection of FF MDI 9.6µg for further evaluation in Phase III trials.

Citation

Citation: Sethi S, Fogarty C, Hanania NA, et al. Efficacy of formoterol fumarate delivered by metered dose inhaler using Co-suspension™ delivery technology versus Foradil® aerolizer® in moderate-to-severe COPD: a randomized, dose-ranging study. J COPD F. 2017; 4(1): 21-33. doi: http://doi.org/10.15326/jcopdf.4.1.2016.0158

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Guiding Principles for the Use of Nebulized Long-Acting Beta2-Agonists in Patients with COPD: An Expert Panel Consensus

Posted in: Original Research, Volume 4 | Issue 1

Robert A. Wise, MD1 Russell A. Acevedo, MD2 Antonio R. Anzueto, MD3 Nicola A. Hanania, MD, MS4 Fernando J. Martinez, MD5 Jill A. Ohar, MD6 Donald P. Tashkin, MD7

Author Affiliations

  1. Johns Hopkins University School of Medicine, Baltimore, Maryland
  2. Crouse Hospital, Syracuse, New York
  3. University of Texas Health Science Center, and South Texas Veterans Health Care System, San Antonio, Texas
  4. Section of Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine, Houston, Texas
  5. Weill Cornell Medical College, New York, New York
  6. Wake Forest Baptist Medical Center, Winston-Salem, North Carolina
  7. David Geffen School of Medicine at the University of California, Los Angeles

Address correspondence to:

Robert A. Wise, MD
Email: rwise@jhmi.edu
Phone: (410)550-0545

Abstract

Determining which patients with COPD may benefit from a nebulized long-acting beta2-agonist (LABA) is a challenge in current practice. In the absence of strong clinical guidelines addressing this issue, an expert panel convened to develop guiding principles for the use of nebulized LABA therapy in patients with COPD. This article summarizes these guiding principles and other practical issues discussed during a roundtable meeting.

Citation

Citation: Wise RA, Acevedo RA, Anzueto AR, et al. Guiding principles for the use of nebulized long-acting beta2-agonists in patients with COPD: An expert panel consensus. J COPD F. 2017; 4(1): 7-20. doi: http://doi.org/10.15326/jcopdf.4.1.2016.0141

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Journal Club: COPD and Rehospitalization

Posted in: Journal Club, Volume 3 | Issue 4

Ron Balkissoon, MD, MSc, DIH, FRCPC1

Author Affiliations

  1. Denver, Colorado

Address correspondence to:

Ron Balkissoon, MD
balkissoonr@njhealth.org

Abstract

This article does not contain an abstract.

Citation

Citation: Balkissoon R. Journal club: COPD and rehospitalization. J COPD F. 2016; 3(4): 791-797. doi: http://doi.org/10.15326/jcopdf.3.4.2016.0167

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A Patient-Centered Walking Program for COPD

Posted in: Editorial, Volume 3 | Issue 4

Sachi O’Hoski, MScPT1 Roger Goldstein, MB, ChB, FRCP(C), FCCP1,2

Author Affiliations

  1. Respiratory Rehabilitation, West Park Healthcare Centre, Toronto, Ontario
  2. Medicine and Physical Therapy, University of Toronto

Address correspondence to:

Roger Goldstein, MD
West Park Healthcare Centre
82 Buttonwood Avenue
Toronto, Ontario M6M 2J5
Email: roger.goldstein@westpark.org

Abstract

This article does not contain an abstract.

Citation

Citation: Goldstein R, O’Hoski S. Editorial-A patient-centered walking program for COPD. J COPD F. 2016; 3(4): 701-704. doi: http://doi.org/10.15326/jcopdf.3.4.2016.0164

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A Patient-Centered Walking Program for COPD

Posted in: Original Research, Volume 3 | Issue 4

Bruce G. Bender, PhD1 Ann Depew, MA2 Amanda Emmett4 Kelly Goelz, MA2 Barry Make, MD2 Sanjay Sharma, Bsc4 Jennifer Underwood2 David Stempel, MD3

Author Affiliations

  1. Departments of Pediatrics, National Jewish Health, Denver, Colorado
  2. Department of Medicine, National Jewish Health, Denver, Colorado
  3. GlaxoSmithKline, Research Triangle Park, North Carolina
  4. Former employee, GlaxoSmithKline

Address correspondence to:

Bruce G. Bender, Ph.D.
National Jewish Health
1400 Jackson Street
Denver, Colorado 80206
303-398-1697
Email: BenderB@njhealth.org

Abstract

Background: Pulmonary rehabilitation programs improve dyspnea and health status associated with chronic obstructive pulmonary disease (COPD), but benefits wane when patients return to a sedentary lifestyle. This study tested a simple, low-resource, low-cost home walking program.

Methods: In this single center, 3-month study, 115 COPD patients were randomized to a control cohort or a goal setting cohort. Each patient met with study staff and received 5 telephone calls at 2-week intervals. During these contacts, the Goal group was assisted by a wellness coach who helped them set personal activity goals. All patients wore a pedometer to record daily steps, the primary study outcome.

Results: Over the 12-week interval, the average step-per-days was 36% higher for the Goal cohort patients (Week 12 mean = 4390) than for Control patients (mean = 3790). No group differences emerged on the modified Medical Research Council (mMRC) dyspnea scale, the COPD Assessment Test, or the St. George’s Respiratory Questionnaire. Secondary analyses indicated that even patients with greater disease severity, including those with an mMRC score >2 or forced expiratory volume in 1 second (FEV1) % predicted below 50%, increased their walking relative to Control patients. Almost half (48%) of Goal patients successfully reached at least one personal goal such as increasing stamina and activity, or decreasing shortness of breath or weight.

Conclusions: A relatively low-resource wellness coaching, goal-setting intervention resulted in a small improvement in the activity level of COPD patients over a 12-week period including those with marked pulmonary impairment. Further investigation should be directed at understanding the optimal blend of in person and remote coaching needed to produce the greatest cost-to-benefit ratio.

Citation

Citation: Bender BG, Depew A, Emmett A, et al. A patient-centered walking program for COPD. J COPD F. 2016; 3(4): 769-777. doi: http://doi.org/10.15326/jcopdf.3.4.2016.0142

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The 2nd National COPD Readmissions Summit and Beyond: From Theory to Implementation

Posted in: Volume 3 | Issue 4, The 2nd National COPD Readmissions Summit

Kristen S. Willard, MS1 Jamie B. Sullivan, MPH1 Byron M. Thomashow, MD2 Catherine S. Jones, PhD, APRN, ANP-C3 Leonard Fromer, MD4 Barbara P. Yawn, MD, MSc5 Alpesh Amin, MD, MBA, MACP6 Jean M. Rommes, PhD7 Rhonda Rotert, MPAS, PA-C8

Author Affiliations

  1. COPD Foundation, Washington, D.C.
  2. Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, Columbia University Medical Center, New York, New York
  3. American Association of Nurse Practitioners and Texas Woman's University, Dallas
  4. University of California-Los Angeles, School of Medicine, Los Angeles
  5. Department of Family and Community Health, University of Minnesota, Blaine
  6. Department of Medicine, University of California, Irvine
  7. Emphysema Foundation for Our Rights to Survive (EFFORTS), Kansas City, Missouri
  8. McFarland Clinic, Ames, Iowa

Address correspondence to:

Kristen S. Willard
Email: kwillard@COPDFoundation.org
Phone: 866-731-2673 ext. 234

Abstract

Chronic obstructive pulmonary disease (COPD) hospitalizations and readmissions adversely impact the health and quality of life of COPD patients. Under the Hospital Readmissions Reduction Program, the Centers for Medicare & Medicaid Services reduce payments to those hospitals exceeding expected rates of COPD readmissions within 30 days of hospital discharge. It was within this climate that the COPD Foundation held its 2nd COPD Readmissions Summit in March 2015. Experts in attendance: (1) categorized challenges to optimal COPD care, ( 2) analyzed the state of care delivery and readmissions reduction strategies and (3) identified the best available evidence-based approaches to improving care delivery across the continuum, including early diagnosis via spirometry, ongoing device, oxygen and medication reconciliation, treatment that addresses comorbidities and preventive care, robust patient education, prompt post-acute follow up, home health services and pulmonary rehabilitation. Results of this collaborative event formed the basis for PRAXIS, the COPD Foundation’s initiative to improve COPD care across the health continuum and to reduce readmissions.

Citation

Citation: Willard KS, Sullivan JB, Thomashow BM, et al. The 2nd National COPD Readmissions Summit and beyond: from theory to implementation. J COPD F. 2016; 3(4): 778-790. doi: http://doi.org/10.15326/jcopdf.3.4.2016.0162

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Efficacy of Indacaterol/Glycopyrronium in Patients with COPD Who Have Increased Dyspnea with Daily Activities

Posted in: Original Research, Volume 3 | Issue 4

Donald A. Mahler, MD1 Dorothy L. Keininger, MSc2 Karen Mezzi, MD2 Robert Fogel, MD3 Donald Banerji, MD3

Author Affiliations

  1. Professor Emeritus, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire
  2. Novartis Pharma AG, Basel, Switzerland
  3. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey

Address correspondence to:

Donald A. Mahler, MD
Valley Regional Hospital
243 Elm Street
Claremont, NH 03743
Tel: (603) 277-0383
Fax: (603) 542-6731
Email: mahlerdonald@gmail.com

Abstract

Introduction: The Global initiative for chronic Obstructive Lung Disease (GOLD) recommends treating patients with chronic obstructive pulmonary disease (COPD) based on a combined assessment of symptom severity and airflow limitation and/or exacerbation risk. According to GOLD, patients with mild-to-moderate airflow limitation and distressing symptoms such as dyspnea should be treated with a long-acting beta2-agonist (LABA) or a long-acting muscarinic antagonist (LAMA). If symptoms persist on monotherapy, GOLD recommends a combination of bronchodilators (LABA/LAMA).

Methods: We performed a post-hoc analysis of data from two 26-week, prospective clinical trials to investigate the effect of treating patients with moderate-to-severe dyspnea with the once-daily LABA/LAMA combination indacaterol/glycopyrronium (IND/GLY) 110/50 µg compared with placebo, once-daily tiotropium 18 µg, and twice-daily salmeterol/fluticasone propionate (SFC) 50/500 µg. In this analysis, a Baseline Dyspnea Index (BDI) score ≤7 was used to identify dyspneic patients.

Results: In dyspneic patients, IND/GLY significantly improved Transition Dyspnea Index (TDI) total scores compared with tiotropium (0.59 units; p<0.05) and SFC (0.97 units; p<0.05), and significantly increased the likelihood of a patient achieving a 1-unit improvement in TDI compared with tiotropium (odds ratio [OR] 1.87; p<0.05). IND/GLY also significantly improved trough forced expiratory volume in 1 second (FEV1) compared with tiotropium and SFC (p<0.001 and p<0.0001, respectively), and significantly reduced rescue medication use compared with tiotropium (p<0.001).

Conclusions: Our analysis indicates that IND/GLY provides additional improvements in dyspnea and lung function compared with tiotropium and SFC in dyspneic patients.

Citation

Citation: Mahler DA, Keininger DL, Mezzi K, Fogel R, Banerji D. Efficacy of indacaterol/glycopyrronium in patients with COPD who have increased dyspnea with daily activities. J COPD F. 2016; 3(4): 758-768. doi: http://doi.org/10.15326/jcopdf.3.4.2016.0138

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