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


OBJECTIVE
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.
Kanniess
Frank
F
Pulmonary Research Institute, Hospital Grosshansdorf, Grosshansdorf, Germany. f.kanniess@klb-healthresearch.com
Boulet
Louis-Philippe
LP
Pierzchala
Wladyslaw
W
Cameron
Ray
R
Owen
Roger
R
Higgins
Mark
M
D000318:Adrenergic beta-Agonists / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007189:Indans / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D015363:Quinolones / Q000008:administration & dosage*; D012720:Severity of Illness Index; D055815:Young Adult
D000318:Adrenergic beta-Agonists; D007189:Indans; D015363:Quinolones; C510790:indacaterol