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Purpose: Patients with chronic obstructive pulmonary disease (COPD) experience impaired health status. Indacaterol is an inhaled, once-daily (od), long-acting β2-agonist for treatment of COPD.
Methods: Two identical randomized, double-blind, 12-week studies (S1 and S2), in moderate-to-severe COPD patients receiving indacaterol 75 μg od or placebo. Bronchodilator effects (trough FEV1 at Week 12) & health status using St George’s Respiratory Questionnaire (SGRQ) were assessed. Changes of 4 units in SGRQ are considered minimal clinically important difference (MCID). Responders (≥ MCID) from all COPD studies with indacaterol 75 μg od vs placebo were analyzed for extent of SGRQ improvement (substantial health status improvement defined as SGRQ change of −8 to −16 units).
Results: 323 patients from S1 and 318 from S2 were randomized. Mean age: 64 and 61 years; post-albuterol FEV1 54% and 55% predicted, FEV1/FVC 52% and 53%. Mean baseline SGRQ scores: 48.4 & 51.3 (indacaterol) vs 49.7 & 50.5 (placebo). At Week 12, SGRQ score improved with indacaterol vs placebo in both studies; mean changes from baseline with indacaterol & placebo, respectively, were −5.8 and −2.0 (S1); −4.9 and −0.9 (S2). In responder analysis, an improvement in SGRQ of at least MCID was more frequent with indacaterol (203/410; 49.5%) vs placebo (618/1564; 39.5%). Higher percent of patients had substantial improvement (−8 to to −16) with indacaterol (23.2%) vs placebo (14.5%). Expressed as percentage of patients with SGRQ response of at least −4 (MCID), 46.8% (95/203) of responders on indacaterol had substantial SGRQ improvements (−8 to −16 units), vs 36.7% (227/618) placebo. The odds ratio (OR) for substantial SGRQ improvement of ≥−8 favored indacaterol (OR 1.52, 95%CI 1.16, 1.99; p=0.0027).
Conclusion: Indacaterol 75 μg od provided significant improvements in health status compared with placebo, with more patients achieving a clinically relevant improvement. Among indacaterol-treated patients with clinically relevant improvements, 46.8% had substantial (≥8 unit) improvement in SGRQ.