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Indacaterol provides sustained 24 h bronchodilation on once‐daily dosing in asthma: a 7‐day dose‐ranging study
Author(s) -
LaForce C.,
Alexander M.,
Deckelmann R.,
Fabbri L. M.,
Aisanov Z.,
Cameron R.,
Owen R.,
Higgins M.
Publication year - 2008
Publication title -
allergy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.363
H-Index - 173
eISSN - 1398-9995
pISSN - 0105-4538
DOI - 10.1111/j.1398-9995.2007.01555.x
Subject(s) - indacaterol , medicine , placebo , dry powder inhaler , dose ranging study , adverse effect , inhaler , anesthesia , asthma , dosing , bronchodilation , tolerability , bronchodilator , spirometry , double blind , alternative medicine , pathology
Background: Indacaterol is a novel, once‐daily β 2 ‐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 (FEV 1 ) 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 FEV 1 ( 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.