Endurance Time During Constant Work Rate Cycle Ergometry in COPD: Development of an Integrated Database From...

Area of Science:

• Pulmonary Medicine and Clinical Trials
• Biomarker Qualification and Clinical Outcome Assessments

Background:

• The COPD Biomarkers Qualification Consortium (CBQC) aims to qualify biomarkers and clinical outcome assessments for chronic obstructive pulmonary disease (COPD).
• Exercise endurance is recognized as a meaningful, patient-centered treatment benefit in COPD, directly impacting daily physical functioning.
• Endurance time during constant work rate cycle ergometry (CWRCE) has been proposed as a valuable efficacy endpoint for COPD clinical trials.

Purpose of the Study:

• To describe the process of creating an integrated database of participant-level endurance time responses to interventions in COPD.
• To compile data from studies utilizing CWRCE as an outcome measure for therapeutic intervention trials in COPD.

Main Methods:

• A systematic literature search identified 553 relevant studies from 2993 publications.
• Participant-level data were requested from investigators for studies involving bronchodilators and rehabilitative exercise training.
• Data extraction focused on studies with sufficient data for two key intervention types.

Main Results:

• The final integrated database includes data from 8 bronchodilator studies (2166 participants) and 15 exercise training studies (3488 participants).
• The database contains 71 variables per participant, including demographics, pulmonary function, and detailed physiological response data.
• This publication details the analysis population; further analyses for validation and qualification will be presented subsequently.

Conclusions:

• An extensive, integrated database of exercise endurance data has been successfully assembled.
• This database provides a foundation for the validation and qualification of CWRCE endurance time as a clinical outcome measure in COPD.
• Subsequent publications will detail the analysis supporting biomarker qualification and address other scientific questions.