Richard Casaburi, PhD, MD1 Debora Merrill, MBA2 Thomas E. Dolmage, MSc3 Judith Garcia-Aymerich, MD, PhD4,5,6 Malin Fageras, PhD7 Roger Goldstein, MD8 Gale Harding, MS9 Nancy Kline Leidy, PhD9 François Maltais, MD10 Denis O’Donnell, MD11 Janos Porszasz, MD, PhD1 Luis Puente-Maestu, PhD, MD12,13 Stephen Rennard, MD14 Frank Sciurba, MD15 Martijn A. Spruit, PhD, PT16 Ruth Tal-Singer, PhD2 Kay Tetzlaff, MD17,18 Alex van ’t Hul, PhD19 Ren Yu, MA9 Alan Hamilton, PhD2
Author Affiliations
- Rehabilitation Clinical Trials Center, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance, California, United States
- COPD Foundation, Miami, Florida, United States
- Respiratory Diagnostic and Evaluation Services and Respiratory Medicine, West Park Healthcare Centre, Toronto, Canada
- ISGlobal, Barcelona, Spain
- Universitat Pompeu Fabra, Barcelona, Spain
- Consorcio de Investigación Biomédica en Red Epidemiología y Salud Pública, Madrid, Spain
- Biopharmaceuticals, Respiratory and Immunology, AstraZeneca, Gothenburg Sweden
- Department of Medicine and Rehabilitation Science, University of Toronto, Toronto, Canada
- Evidera, Bethesda, Maryland, United States
- Université Laval, Quebec, Canada
- Respiratory Investigation Unit, Department of Medicine, Queen's University and Kingston Health Sciences Centre, Kingston, Ontario, Canada
- Hospital General Universitario Gregorio Marañón Universidad, Madrid, Spain
- Complutense de Madrid-Medical School, Madrid, Spain
- Division of Pulmonary, Critical Care and Sleep Medicine, Department of Internal Medicine, University of Nebraska Medical Center, Omaha, Nebraska, United States
- Division of Pulmonary, Allergy and Critical Care Medicine, Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, United States
- Department of Research and Development, Ciro, Horn and Department of Respiratory Medicine, Maastricht University Medical Centre, Maastricht, Netherlands
- Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany
- Department of Sports Medicine, University of Tübingen, Tübingen, Germany
- Department of Respiratory Diseases, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands
Address correspondence to:
Richard Casaburi, PhD, MD
Rehabilitation Clinical Trials Center
The Lundquist Institute at Harbor UCLA Medical Center
CDCRC Building
1124 W. Carson St.
Torrance, CA 90502
Email: casaburi@ucla.edu
Phone: (310) 222-8200
Abstract
Introduction: The COPD Biomarkers Qualification Consortium (CBQC) was formed under COPD Foundation management, with the goal of qualifying biomarkers and clinical outcome assessments through established regulatory processes for chronic obstructive pulmonary disease (COPD). Within CBQC, a working group evaluated opportunities for qualification of an exercise endurance measure. In a recent publication (Chronic Obstr Pulm Dis. 2022; 9[2]:252-265), we described a conceptual framework establishing exercise endurance’s direct relationship to an individual with COPD’s experience of physical functioning in daily life, and that increase in exercise endurance is a patient-centered, meaningful treatment benefit. We further proposed endurance time during constant work rate cycle ergometery (CWRCE) as a useful efficacy endpoint in clinical therapeutic intervention trials. In this current publication, we describe the process of assembling an integrated database of endurance time responses to interventions in COPD.
Methods: We sought participant-level data from published studies incorporating CWRCE as an outcome measure. A literature search screened 2993 publications and identified 553 studies for assessment. Two interventions had sufficient data across studies to warrant data extraction: bronchodilators and rehabilitative exercise training. Investigators were contacted and requested to provide participant-by-participant data from their published studies.
Results: The final dataset included data from 8 bronchodilator studies (2166) participants and 15 exercise training studies (3488 participants). The database includes 71 variables per participant, comprising demographic, pulmonary function, and detailed physiologic response data. This paper provides a detailed description of the analysis population, while analysis supporting the validation/qualification process and addressing other scientific questions will be described in subsequent publications.
Citation
Citation: Casaburi R, Merrill D, Dolmage T, et al. Endurance time during constant work rate cycle ergometry in COPD: development of an integrated database from interventional studies. J COPD F. 2022; 9(4): 520-537. doi: http://doi.org/10.15326/jcopdf.9.4.2022.0331