24-h bronchodilator efficacy of single doses of indacaterol in Japanese patients with asthma: a comparison with placebo and salmeterol.

Abstract

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.

CONCLUSION:

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.

• Authors: Naruhiko Sugihara, Shigeto Kanada, Michiko Haida, Masakazu Ichinose, Mitsuru Adachi, Motoi Hosoe, Charlotte Emery, Mark Higgins, Benjamin Kramer
• Journal: Respiratory medicine (Respir Med) Vol. 104 Issue 11 Pg. 1629-37 (Nov 2010) ISSN: 1532-3064 [Electronic] England
• PMID: 20619623 (Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 Elsevier Ltd. All rights reserved.

Chemical References

• Bronchodilator Agents
• Indans
• Placebos
• Quinolones
• Salmeterol Xinafoate
• indacaterol
• Albuterol

Topics

• Administration, Inhalation
• Adolescent
• Adult
• Aged
• Albuterol (administration & dosage, analogs & derivatives)
• Asthma (drug therapy, physiopathology)
• Bronchodilator Agents (administration & dosage)
• Cross-Over Studies
• Double-Blind Method
• Female
• Forced Expiratory Volume (physiology)
• Humans
• Indans (administration & dosage)
• Japan
• Male
• Middle Aged
• Placebos
• Practice Guidelines as Topic
• Quinolones (administration & dosage)
• Respiratory Function Tests
• Salmeterol Xinafoate
• Treatment Outcome
• Young Adult