Indacaterol is an inhaled, once-daily long-acting β 2-agonist bronchodilator for regular use in patients with chronic obstructive pulmonary disease (COPD). As indacaterol is the first once-daily β 2-agonist to be developed, it is relevant to evaluate its bronchodilator efficacy, safety, and tolerability.
Data were pooled from three randomized, double-blind, clinical studies in patients with moderate-to-severe COPD treated with indacaterol 150 μg qd (n = 627) or placebo (n = 1021). Bronchodilator efficacy was assessed as trough (24-hour post-dose) forced expiratory volume in 1 second (FEV 1) after 12 weeks (primary endpoint in individual studies) and FEV 1 measured serially post-dose. Rescue use of albuterol was monitored.
At week 12, indacaterol increased trough FEV 1 by 160 mL compared with placebo ( P < 0.001), exceeding the 120 mL level prespecified as clinically important. FEV 1 during the first 12-hour post-dose at week 12 averaged 210 mL higher with indacaterol than with placebo ( P < 0.001). Patients receiving indacaterol recorded 53% of days without use of rescue albuterol, compared with 38% of days in the placebo group ( P < 0.001). Adverse events (mostly mild or moderate) were reported for 52% and 46% of patients receiving indacaterol and placebo, respectively, and serious adverse events for 4% and 5%. Worsening of COPD was the most frequent adverse event (10% indacaterol; 15% placebo). Indacaterol had little effect on pulse or blood pressure or measures of systemic β 2-adrenoceptor activity (blood glucose, serum potassium, and corrected QT interval).