TY - JOUR
T1 - 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
AU - CBQC Constant Work Rate Exercise Working Group
AU - Casaburi, Richard
AU - Merrill, Debora D.
AU - Harding, Gale
AU - Leidy, Nancy Kline
AU - Rossiter, Harry B.
AU - Tal-Singer, Ruth
AU - Hamilton, Alan
AU - Cooper, Christopher B.
AU - Hopkinson, Nick
AU - Locantore, Nicholas
AU - Maltais, Francois
AU - Mohan, Divya
AU - Neder, Alberto
AU - Noronha, Andrea
AU - O’Donnell, Dennis
AU - Polkey, Michael
AU - Porszasz, Janos
AU - Rennard, Stephen
AU - Sciurba, Frank
AU - Singh, Sally J.
AU - Spruit, Martijn A.
AU - Walker, Martyn
AU - Ward, Susan
AU - Yu, Ren
N1 - Publisher Copyright:
© 2022 Copyright Chronic Obstructive Pulmonary Diseases: Journal of the COPD Foundation.
PY - 2022
Y1 - 2022
N2 - 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 as 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. 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 direct relationship to the experience of physical functioning in daily life, which is a patient-centered meaningful benefit.
AB - 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 as 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. 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 direct relationship to the experience of physical functioning in daily life, which is a patient-centered meaningful benefit.
KW - COPD
KW - Clinical outcome assessment
KW - Drug development
KW - Exercise endurance
KW - Physical functioning
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U2 - 10.15326/JCOPDF.2021.0258
DO - 10.15326/JCOPDF.2021.0258
M3 - Article
AN - SCOPUS:85123678159
SN - 2372-952X
VL - 9
JO - Chronic Obstructive Pulmonary Diseases
JF - Chronic Obstructive Pulmonary Diseases
IS - 1
ER -