Large clinical trials in chronic obstructive pulmonary disease (COPD) are analyzed and discussed. Unfortunately, all of them have failed to reach their primary endpoint, which has mainly been the effect on the rate of decline in mean FEV1 (forced expiratory volume in 1 second). Nonetheless, almost all trials have demonstrated benefits in important outcomes such as exacerbation frequency, symptoms, quality of life and other measures of health status, which are arguably more meaningful to individual patients than FEV 1 per se.
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