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Assessment tools for chronic obstructive pulmonary disease: do newer metrics allow for disease modification?
Donald A Mahler1, Gerard J Criner
1Division of Pulmonary and Critical Care Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.
Proceedings of the American Thoracic Society
|September 20, 2007
Summary
This study redefines disease modification in chronic obstructive pulmonary disease (COPD) beyond FEV1 decline. It explores new metrics like inspiratory capacity and health status for assessing long-term treatment effects in COPD patients.
Area of Science:
- Pulmonary Medicine
- Respiratory Research
- Clinical Trial Design
Background:
- Traditionally, Forced Expiratory Volume in 1 second (FEV1) decline defines chronic obstructive pulmonary disease (COPD) progression.
- Current COPD treatments primarily aim to slow FEV1 decline.
- A broader definition of disease modification is needed to capture comprehensive treatment effects.
Purpose of the Study:
- To propose an expanded definition of "disease modification" in COPD.
- To identify and evaluate alternative metrics for assessing disease modification beyond FEV1.
- To review data on newer modalities that could serve as valid endpoints for COPD therapies.
Main Methods:
- Literature review of available longitudinal and predictive data.
- Analysis of established and emerging metrics for COPD assessment.
- Consideration of data from disease-modifying therapies.
Main Results:
- Proposed definition: Disease modification is any sustained change in a relevant disease metric.
- Identified potential alternative metrics: inspiratory capacity, exercise capacity, 6-minute walk distance, dyspnea, health status, multidimensional indices, and exacerbations.
- Discussed the impact of disease-modifying therapies on these alternative metrics.
Conclusions:
- The traditional focus on FEV1 may be insufficient for evaluating comprehensive COPD disease modification.
- Emerging metrics offer a more holistic approach to assessing treatment efficacy in COPD.
- Further research is warranted to validate these alternative metrics as endpoints in clinical trials.
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