24-h bronchodilator efficacy of single doses of indacaterol in Japanese patients with asthma: a comparison with placebo and salmeterol.
BACKGROUND
Indacaterol is a novel, inhaled once-daily ultra-long-acting beta-2 agonist under development as a fixed-dose combination with an inhaled corticosteroid (ICS) for asthma treatment. This study evaluated the 24-h bronchodilator efficacy of indacaterol in Japanese patients with asthma.


METHODS
Randomised, placebo-controlled, 5-period crossover study. Patients with persistent asthma (18-75 years, FEV(1) 50-85% predicted, ≥12% and 200 mL FEV(1) reversibility) receiving ICS were randomised to double-blind single dose indacaterol 150, 300, or 600 μg or placebo, with open-label salmeterol 50 μg twice-daily for one day in the 5(th) period. Primary endpoint was FEV(1)AUC(22-24h).


RESULTS
Of 41 randomised patients (48.8% male; mean age: 47.8 years), 39 completed. All indacaterol doses showed significantly higher FEV(1)AUC(22-24h) than placebo (P<0.001), with treatment-placebo differences of 180, 220, and 260 mL for indacaterol 150, 300, and 600 μg, respectively (salmeterol-placebo difference 170 mL; P < 0.001). For individual time-point FEV(1), all indacaterol doses were superior to placebo from 5 min to 24h post-dose (P < 0.001). Compared with salmeterol, all indacaterol doses were superior from 5 to 30 min (P < 0.05); in addition indacaterol 300 μg and 600 μg were superior at a number of subsequent time points. Changes in safety parameters with indacaterol were similar to placebo. All indacaterol doses were well tolerated.


CONCLUSIONS
Single dose indacaterol provided sustained 24-h bronchodilation with a faster onset of action than salmeterol and a good overall safety and tolerability profile in Japanese patients with asthma. These results are consistent with data from Caucasian populations.
Sugihara
Naruhiko
N
Jinyu Clinic Hospital, Jinyukai Healthcare Corporation, Tokyo, Japan.
Kanada
Shigeto
S
Haida
Michiko
M
Ichinose
Masakazu
M
Adachi
Mitsuru
M
Hosoe
Motoi
M
Emery
Charlotte
C
Higgins
Mark
M
Kramer
Benjamin
B
D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000420:Albuterol / Q000008:administration & dosage / Q000031:analogs & derivatives*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000502:physiology; D006801:Humans; D007189:Indans / Q000008:administration & dosage*; D007564:Japan; D008297:Male; D008875:Middle Aged; D010919:Placebos; D017410:Practice Guidelines as Topic; D015363:Quinolones / Q000008:administration & dosage*; D012129:Respiratory Function Tests; D000068299:Salmeterol Xinafoate; D016896:Treatment Outcome; D055815:Young Adult
D001993:Bronchodilator Agents; D007189:Indans; D010919:Placebos; D015363:Quinolones; D000068299:Salmeterol Xinafoate; C510790:indacaterol; D000420:Albuterol