Indacaterol provides sustained 24 h bronchodilation on once‐daily dosing in asthma: a 7‐day dose‐ranging study
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abstract
Background: 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.Objective: A dose‐ranging study was undertaken to evaluate efficacy and safety of indacaterol.Methods: 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™), 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.Results: 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 ≤ 0.001 vs placebo) on days 1 and 7, with clinically relevant treatment‐placebo differences of 240, 260, 350, 300, and 380 ml on day 1 and 230, 220, 320, 250, and 270 ml on day 7 for indacaterol 50, 100, 200, and 400 μg via MDDPI and 400 μg via SDDPI, respectively. All doses increased mean FEV1 (P < 0.05 vs placebo) from 5 min to 24 h postdose on days 1 and 7. All doses were well tolerated. Most adverse events were mild‐to‐moderate in severity: most frequently reported were respiratory, thoracic, and mediastinal disorders.Conclusion: 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.
