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Changing patterns in long-acting bronchodilator trials in chronic obstructive pulmonary disease
James F Donohue1, Paul W Jones
1Division of Pulmonary Disease and Critical Care Medicine, School of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA. jdonohue@med.unc.edu
International Journal of Chronic Obstructive Pulmonary Disease
|February 12, 2011
Summary
Recent clinical trials for chronic obstructive pulmonary disease (COPD) show changing trends. Spirometry improvements and decline rates differ from earlier studies, impacting trial design and patient selection for COPD management.
Area of Science:
- Pulmonology
- Clinical Trials
- Respiratory Medicine
Background:
- Chronic obstructive pulmonary disease (COPD) significantly impacts global morbidity and mortality.
- Established guidelines for COPD diagnosis, treatment, and spirometry have shaped clinical trial designs.
- Recent COPD trials exhibit evolving trends compared to historical studies.
Purpose of the Study:
- To explore the impact of changing variables on clinical trial results in COPD.
- To analyze shifts in inclusion criteria and patient baseline demographics in recent COPD trials.
Main Methods:
- Review of large bronchodilator studies and their reported outcomes.
- Analysis of trends in forced expiratory volume in 1 second (FEV(1)) improvements and decline rates.
- Examination of changes in patient populations, concomitant medications, and inclusion criteria.
Main Results:
- Recent bronchodilator studies show diminished FEV(1) improvements versus placebo compared to earlier trials.
- The rate of FEV(1) decline appears to be slower in contemporary COPD trials.
- The utility of bronchodilator reversibility testing as a trial inclusion criterion is increasingly questioned.
Conclusions:
- Evolving patient demographics, increased treatment options, and altered trial methodologies influence COPD clinical trial outcomes.
- Changes in inclusion criteria and baseline characteristics necessitate a re-evaluation of COPD trial interpretation.
- Understanding these trends is crucial for the accurate assessment of new COPD therapies.
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