Effect of once‐daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: A 26‐week Asia‐Pacific study. Issue 2 (3rd January 2014)

• Record Type: Journal Article
• Authors: Yao, Wanzhen; Wang, Changzheng; Zhong, Nanshan; Han, Xiaowen; Wu, Changgui; Yan, Xixin; Chen, Ping; Yang, Wei; Henley, Michelle; Kramer, Benjamin
• Is Part Of: Respirology. Volume 19:Issue 2(2014)
• Page Start: 231
• Page End: 238
• Publication Date: 2014-01-03
• Subjects: Respiratory organs -- Diseases -- Periodicals; Respiratory organs -- Periodicals; 612.2
• DOI: 10.1111/resp.12211
• Languages: English
• ISSNs: 1323-7799

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="resp12211-sec-0001" sec-type="section"> <title>Background and objective</title> <p>This study, in a predominantly Chinese population, investigated the efficacy and safety of a once‐daily (o.d.) inhaled ultra‐long‐acting β<sub>2</sub>‐agonist indacaterol for the treatment of moderate‐to‐severe chronic obstructive pulmonary disease (COPD).</p> </sec> <sec id="resp12211-sec-0002" sec-type="section"> <title>Methods</title> <p>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 (FEV<sub>1</sub>, 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.</p> </sec> <sec id="resp12211-sec-0003" sec-type="section"> <title>Results</title> <p>Of the 563 patients randomized, 561 (89.8% Chinese) received treatment and 482 completed. At Week 12, trough FEV<sub>1</sub> improved significantly for indacaterol 150 and 300 μg versus placebo (1.32, 1.29 vs 1.17; <italic>P</italic> < 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; <italic>P</italic> < 0.01), as was the percentage of patients with a clinically relevant improvement (≥1 point) (74.1%, 78.6% vs 55.5%; <italic>P</italic> < 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.</p> </sec> <sec id="resp12211-sec-0004" sec-type="section"> <title>Conclusions</title> <p>Indacaterol delivered effective bronchodilation with significant improvements in breathlessness and health status in this predominantly Chinese population.</p> </sec> </abstract>