Indacaterol therapy in patients with COPD not receiving other maintenance treatment

Background: Recent findings of rapid lung function decline in younger patients with moderate COPD severity suggest the need for effective early treatment. Aim: To evaluate the effectiveness of indacaterol as maintenance therapy in COPD patients not receiving other maintenance treatments. Methods: Pooled data from three randomised, placebo-controlled studies provided a population of patients with moderate-to-severe COPD not receiving maintenance treatment at baseline and who received once-daily, double-blind treatment with indacaterol 150 mu g, indacaterol 300 mu g or placebo. Data from an open-label tiotropium treatment arm in one study were available for comparison. Efficacy evaluations included trough FEV1, dyspnoea (transition dyspnoea index, TDI) and health status (St George's Respiratory Questionnaire, SGRQ) at 6 months and risk of COPD exacerbations. Results: The maintenance-naive population comprised 232 (indacaterol 150 mu g), 220 (indacaterol 300 mu g) and 325 (placebo) patients, plus 156 (tiotropium) (30% of overall study population). Patients treated with indacaterol 150 and 300 mu g had statistically significant improvements relative to placebo (p < 0.05) in trough FEV1 (170 and 180 mL), TDI total score (1.27 and 1.04 points), rescue use and SGRQ total score (-6.1 and -2.5 units) at 6 months. Patients receiving tiotropium had statistically significant improvements versus placebo (p < 0.05) in trough FEV1 (130 mL) and TDI total score (0.69 points). Exacerbations were rare and not significantly reduced by any treatment. Treatments were well tolerated. Conclusions: Indacaterol, given to patients with moderate-to-severe COPD not receiving other maintenance treatments, provided effective bronchodilation with significant, clinically relevant improvements in dyspnoea and health status compared with placebo. (C) 2012 Elsevier Ltd. All rights reserved.