Indacaterol provides sustained 24 h bronchodilation on once-daily dosing in asthma: a 7-day dose-ranging study
2008
LaForce, C. | Alexander, M. | Deckelmann, R. | Fabbri, L.M. | Aisanov, Z. | Cameron, R. | Owen, R. | Higgins, M.
Indacaterol is a novel, once-daily β₂-agonist in development for the treatment of asthma and chronic obstructive pulmonary disease. Studies were required to determine optimal dose(s) for continuing investigation. A dose-ranging study was undertaken to evaluate efficacy and safety of indacaterol. A total of 436 patients with persistent asthma receiving inhaled corticosteroids were randomized to 7 days treatment with once-daily indacaterol 50, 100, 200, or 400 μg via multi-dose dry-powder inhaler (MDDPI; Certihaler[trade mark sign]), indacaterol 400 μg via single-dose dry-powder inhaler (SDDPI), or placebo. Serial 24-h spirometry was performed on days 1 and 7. Vital signs, laboratory evaluations, and adverse events were monitored. All doses of indacaterol increased the mean time-standardized area under the curve of forced expiratory volume in 1 s (FEV₁) from 22 to 24 h postdose (P Once-daily dosing with indacaterol provided sustained 24-h bronchodilation in patients with moderate-to-severe asthma, with a satisfactory overall safety profile. Indacaterol 200 μg appears the optimum dose, offering the best efficacy/safety balance.
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