Indacaterol therapy in patients with COPD not receiving other maintenance treatment

Abstract

Recent findings of rapid lung function decline in younger patients with moderate COPD severity suggest the need for effective early treatment. To evaluate the effectiveness of indacaterol as maintenance therapy in COPD patients not receiving other maintenance treatments. 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 μg, indacaterol 300 μg 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. The maintenance-naïve population comprised 232 (indacaterol 150 μg), 220 (indacaterol 300 μg) and 325 (placebo) patients, plus 156 (tiotropium) (30% of overall study population). Patients treated with indacaterol 150 and 300 μg 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. 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.