Marc Decramer1, Andrea Rossi, David Lawrence, Danny McBryan. 1. Respiratory Division, University Hospitals, Chief Respiratory Division UZ Leuven, Campus Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium. Marc.Decramer@uzleuven.be
Abstract
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 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. RESULTS: 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. 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.
RCT Entities:
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 COPDpatients 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 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. RESULTS: 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. 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.
Authors: Dave Singh; Anthony D D'Urzo; James F Donohue; Edward M Kerwin; Eduard Molins; Ferran Chuecos; Anna Ribera; Diana Jarreta Journal: Int J Chron Obstruct Pulmon Dis Date: 2019-12-06