Efficacy of a new once-daily long-acting inhaled 2-agonist indacaterol versus twice-daily formoterol in COPD

Abstract

Background Indacaterol is a long-acting inhaled β₂-agonist (LABA) for the treatment of chronic obstructive pulmonary disease (COPD). In previous studies, indacaterol provided 24 h bronchodilation on once-daily dosing with a fast onset of action. This study compared the efficacy and safety of indacaterol with the twice-daily LABA formoterol and placebo over 1 year. Methods Patients with moderate to severe COPD were randomised to receive once-daily indacaterol 300 μg (n=437) or 600 μg (n=428), twice-daily formoterol 12 μg (n=435) or placebo (n=432) for 52 weeks in a double-blind double-dummy parallel group study. The primary efficacy variable was forced expiratory volume in 1 s (FEV₁) measured 24 h postdose after 12 weeks (indacaterol vs placebo). Other outcomes included dyspnoea (transition dyspnoea index, TDI), use of as-needed salbutamol, symptom-based measures recorded on diary cards, exacerbations, health status (St George's Respiratory Questionnaire), BODE index (body mass index, obstruction, dyspnoea, exercise), safety and tolerability. Results Indacaterol increased 24 h postdose FEV₁ after 12 weeks by 170 ml (both doses) versus placebo and by 100 ml versus formoterol (all p2-mediated events. Conclusions Once-daily indacaterol is an effective 24 h bronchodilator that improves symptoms and health status and confers clinical improvements over a twice-daily 12 h LABA as a treatment for patients with moderate to severe COPD. Trial registration number NCT 00393458.