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
- Pulmonary Research Institute of Southeast Michigan, Farmington Hills, Michigan
- Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut
- College of Physicians and Surgeons, Columbia University, New York, New York
- Johns Hopkins University School of Medicine, Baltimore, Maryland
- St Francis Hospital Medical Center, Hartford, Connecticut
- 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
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: Ferguson GT, Beck B, Clerisme-Beaty E, et al. Recruiting patients after hospital discharge for acute exacerbation of COPD: Challenges and lessons learned. Chronic Obstr Pulm Dis. 2017; 4(4): 265-278. doi: http://dx.doi.org/10.15326/jcopdf.4.4.2016.0176
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
- Pulmonary Section, Veterans Administration Pittsburgh Healthcare System, Pittsburgh, Pennsylvania
- Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
- Children’s Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania
- The MED Group, Inc., Lubbock, Texas
- Vapotherm, Inc., Exeter, New Hampshire
- 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
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: 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. Chronic Obstr Pulm Dis. 2017; 4(4): 279-286. doi: http://dx.doi.org/10.15326/jcopdf.4.4.2016.0169
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
- Division of Pulmonary, Critical Care, Sleep and Allergy, Department of Medicine, University of Illinois at Chicago
- Jesse Brown Veterans Administration Medical Center, Chicago, Illinois
- 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
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: Zaidi F, Lee RS, Buchcic BA, et al. Evaluation and documentation of supplemental oxygen requirements is rarely performed in patients hospitalized with COPD. Chronic Obstr Pulm Dis. 2017; 4(4): 287-296. doi: http://dx.doi.org/10.15326/jcopdf.4.4.2017.0148
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
- Division of Pulmonary and Critical Care Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
- Division of Pulmonary and Critical Care Medicine, University of Michigan Health System, Ann Arbor
- Department of Radiology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
- Asthma and Airway Disease Research Center and Department of Medicine, University of Arizona, Tucson; and ISGlobal CREAL and Pompeu Fabra University, Barcelona, Spain
- Lovelace Respiratory Research Institute, Albuquerque, New Mexico
- 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
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: 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. Chronic Obstr Pulm Dis. 2017; 4(4): 297-304. doi: http://dx.doi.org/10.15326/jcopdf.4.4.2017.0150