Efficacy of Inhaled Steroids in Undiagnosed Subjects at High Risk for COPD

Background and aim: COPD leads to a progressive decline of pulmonary function. Family physicians treat a substantial number of patients with COPD and are encouraged to start treatment at as early a stage as is possible. This study analyzed the effectiveness of early inhaled corticosteroid treatment on the decline of pulmonary function in COPD patients. Patients and setting: Subjects with a rapid decline in lung function (ie, FEV1 decline, > 80 mL/yr) who had never before received a diagnosis of asthma or COPD. Methods: Two-year, randomized, controlled, double-blind clinical trial of fluticasone propionate (250 g bid; 24 patients) or placebo (25 patients), followed by a 7-month open-label study in which all subjects received fluticasone propionate. The primary outcome was the post-bronchodilator therapy FEV1, and secondary outcomes were respiratory symptoms, exacerbations, health state, quality of life, and health-care utilization. Results: After 31 months, there were no statistical differences in post-bronchodilator therapy FEV1 between the intervention group and the control group. No statistical differences were observed for symptoms, exacerbations, or quality of life, although tendencies were consistently in favor of treatment. There was no significant impact on the direct or indirect costs. Conclusions: There are no indications that early treatment with inhaled corticosteroids modifies a rapid decline in lung function or respiratory symptoms and quality of life. (CHEST 2004; 126:1815–1824)