A conceptual framework for use of increased endurance time during constant work rate cycle ergometry as a patient-focused meaningful outcome in copd clinical trials.
Author(s)
Type
Journal Article
Abstract
The Chronic Lung Disease Biomarker and Clinical Outcome Assessment Qualification Consortium (CBQC) evaluates the potential of biomarkers and outcome measures as drug development tools. Exercise endurance is an objective indicator of treatment benefit, closely related to daily physical function. Therefore, it is an ideal candidate for an outcome for drug development trials. Unfortunately, no exercise endurance measure is qualified by regulatory authorities for use in trials of chronic obstructive pulmonary disease (COPD) and no approved COPD therapies have claims of improving exercise endurance. Consequently, it has been challenging for developers to consider this outcome when designing clinical trials for new therapies. Endurance time during constant work rate cycle ergometry (CWRCE), performed on an electronically braked stationary cycle ergometer, provides an exercise endurance measure under standardized conditions. Baseline individualized work rate for each participant is set using an incremental test. During CWRCE the patient is encouraged to continue exercising for as long as possible. Although not required, physiological and sensory responses (e.g., pulmonary ventilation, heart rate, dyspnea ratings) are frequently collected to support interpretation of endurance time changes. Exercise tolerance limit is reached when the individual is limited by symptoms, unable to maintain pedaling cadence or unable to continue safely. At exercise cessation, exercise duration is recorded. An CWRCE endurance time increase from the pre-treatment baseline is proposed as a key efficacy endpoint in clinical trials. In COPD, improved exercise endurance has a direct relationship to the experience of physical functioning in daily life, which is a patient-centered, meaningful benefit.
Date Issued
2022-04-29
Date Acceptance
2022-01-05
Citation
Chronic obstructive pulmonary diseases (Miami, Fla.), 2022, 9 (2), pp.252-265
ISSN
2372-952X
Publisher
Taylor and Francis Group
Start Page
252
End Page
265
Journal / Book Title
Chronic obstructive pulmonary diseases (Miami, Fla.)
Volume
9
Issue
2
Copyright Statement
Copyright 2022 by COPD Foundation.
Identifier
https://www.ncbi.nlm.nih.gov/pubmed/35018752
Subjects
clinical outcome assessment
copd
drug development
exercise endurance
physical functioning
Publication Status
Published
Coverage Spatial
United States
Date Publish Online
2022-01-10