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Efficacy and safety of indacaterol, a new 24-hour beta2-agonist, in patients with asthma: a dose-ranging study.

AbstractBACKGROUND:
Indacaterol is a new once-daily inhaled beta(2)-agonist in clinical development for asthma as a component of a fixed-dose combination with an inhaled corticosteroid.
OBJECTIVES:
To investigate the efficacy and safety of indacaterol in patients with chronic persistent asthma.
METHODS:
A total of 115 patients were randomized in a double-blind, incomplete-block cross-over design to sequences of four 7-day treatment periods (separated by 7-day washouts) with indacaterol 100, 200, 300, 400, or 600 micro g or placebo, once daily, via single-dose dry-powder inhaler. After the fourth washout, patients received 1 day of open-label formoterol 12 mu g twice daily. Forced expiratory volume in 1 second (FEV(1)) was measured for 24 hours post-dose on days 1 and 7.
RESULTS:
For standardized (with respect to time) FEV(1) area under the curve at 22 to 24 hours (AUC(22-24h)) on day 1, indacaterol doses >or=200 micro g were superior to placebo (p < 0.05) and similar or greater than formoterol 12 micro g twice daily. By day 7, mean differences from placebo in FEV(1) standardized AUC(22-24h) were 0.08, 0.16, 0.15, 0.11, and 0.16 L for indacaterol 100, 200, 300, 400, and 600 micro g, respectively (all p < 0.05 vs. placebo). Mean FEV(1) for indacaterol doses >or= 200 micro g on day 7 was higher than placebo (p < 0.05) pre-dose and at all post-dose time points. AEs were generally mild in severity; no serious AEs occurred. No clinically meaningful differences were observed between treatments in any safety assessments.
CONCLUSIONS:
Once-daily indacaterol demonstrated sustained 24-hour bronchodilator efficacy, with similar efficacy on days 1 and 7, and was generally well tolerated.
AuthorsFrank Kanniess, Louis-Philippe Boulet, Wladyslaw Pierzchala, Ray Cameron, Roger Owen, Mark Higgins
JournalThe Journal of asthma : official journal of the Association for the Care of Asthma (J Asthma) Vol. 45 Issue 10 Pg. 887-92 (Dec 2008) ISSN: 1532-4303 [Electronic] England
PMID19085578 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Adrenergic beta-Agonists
  • Indans
  • Quinolones
  • indacaterol
Topics
  • Adrenergic beta-Agonists (administration & dosage)
  • Adult
  • Aged
  • Asthma (drug therapy)
  • Cross-Over Studies
  • Double-Blind Method
  • Female
  • Humans
  • Indans (administration & dosage)
  • Male
  • Middle Aged
  • Quinolones (administration & dosage)
  • Severity of Illness Index
  • Young Adult

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