Effect of once-daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: a 26-week Asia-Pacific study.

Abstract

BACKGROUND AND OBJECTIVE:

This study, in a predominantly Chinese population, investigated the efficacy and safety of a once-daily (o.d.) inhaled ultra-long-acting β2 -agonist indacaterol for the treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD).

METHODS:

This is a 26-week, double-blind study on randomized patients who received indacaterol 150 μg or 300 μg or placebo o.d. The primary variable was trough forced expiratory volume in 1 s (FEV1 , average of 23 h 10 min and 23 h 45 min post-dose values) at Week 12. Health status (St George's Respiratory Questionnaire, SGRQ), dyspnoea (transition dyspnoea index, TDI) and safety were evaluated over 26 weeks.

RESULTS:

Of the 563 patients randomized, 561 (89.8% Chinese) received treatment and 482 completed. At Week 12, trough FEV1 improved significantly for indacaterol 150 and 300 μg versus placebo (1.32, 1.29 vs 1.17; P < 0.001 for both comparisons), with differences exceeding the pre-specified minimal clinically important difference of 0.12 L. At Week 26, TDI score was superior to placebo for indacaterol 150 and 300 μg (0.82, 1.15; P < 0.01), as was the percentage of patients with a clinically relevant improvement (≥1 point) (74.1%, 78.6% vs 55.5%; P < 0.05). Both doses provided ≥4-point improvements from baseline in SGRQ score at Week 26 that were numerically greater than placebo (unadjusted means: -9.6, -8.8 vs -7.0), with a similar pattern in percentage of patients with clinically relevant improvements in SGRQ score (65.0%, 61.5% vs 60.6%). Incidences of adverse events were comparable across treatment groups.

CONCLUSIONS:

Indacaterol delivered effective bronchodilation with significant improvements in breathlessness and health status in this predominantly Chinese population.

• Authors: Wanzhen Yao, Changzheng Wang, Nanshan Zhong, Xiaowen Han, Changgui Wu, Xixin Yan, Ping Chen, Wei Yang, Michelle Henley, Benjamin Kramer
• Journal: Respirology (Carlton, Vic.) (Respirology) Vol. 19 Issue 2 Pg. 231-238 (Feb 2014) ISSN: 1440-1843 [Electronic] Australia
• PMID: 24383720 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: © 2014 The Authors. Respirology © 2014 Asian Pacific Society of Respirology.

Chemical References

• Indans
• Quinolones
• indacaterol

Topics

• Aged
• China (epidemiology)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Administration Schedule
• Female
• Follow-Up Studies
• Forced Expiratory Volume (drug effects)
• Health Status
• Humans
• Incidence
• Indans (administration & dosage)
• Male
• Middle Aged
• Pulmonary Disease, Chronic Obstructive (drug therapy, epidemiology, physiopathology)
• Quinolones (administration & dosage)
• Surveys and Questionnaires
• Time Factors
• Treatment Outcome