Bronchodilator efficacy of indacaterol, a novel once-daily β2-agonist, in patients with persistent asthma

Background: Indacaterol is a novel once-daily inhaled beta(2)-agonist in development for the treatment of patients with asthma or chronic obstructive pulmonary disease. Objective: To investigate the bronchodilator efficacy of indacaterol in patients with persistent asthma. Methods: Patients received a randomized sequence of single doses of indacaterol, 400 mu g, via single-dose dry powder inhaler (SDDPI); indacaterol, 200 mu g, via multidose dry powder inhaler (MDDPI); and placebo. At each visit, the forced expiratory volume in 1 second (FEV(1)) was recorded at a series of time points during a 24-hour period. Results: Of 33 patients screened, 25 were randomized to treatment. Adjusted mean FEV(1), was significantly higher (P <= .005) for both indacaterol doses vs placebo at most time points. The first time points at which statistically significant treatment differences were observed for indacaterol and placebo in FEV(1) were 0.17 L at 5 minutes after dosing for 400 mu g of indacaterol (SDDPI) and 0.21 L at 10 minutes for 200 mu g of indacaterol (MDDPI) (both P <.001 vs placebo). Differences relative to placebo at the final time point, 24 hours after dosing, were 0.29 L and 0. 15 L for indacaterol, 400 mu g and 200 mu g, respectively (both P <= .003 vs placebo). Overall, FEV(1) was significantly higher for the 400-mu g dose compared with the 200-mu g dose from 15 minutes to 2 hours after dosing (P <= 0.13) and from 5 hours onward (P <= .022). Indacaterol was associated with good tolerability and safety. Conclusions: Indacaterol demonstrates sustained bronchodilator efficacy throughout the full 24-hour period, with a rapid onset of action and a good overall safety profile.