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- Title
Effect of once-daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: A 26-week Asia- Pacific study.
- Authors
Yao, Wanzhen; Wang, Changzheng; Zhong, Nanshan; Han, Xiaowen; Wu, Changgui; Yan, Xixin; Chen, Ping; Yang, Wei; Henley, Michelle; Kramer, Benjamin
- 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.
- Subjects
INDACATEROL; OBSTRUCTIVE lung diseases; ADRENERGIC beta agonists; RESPIRATORY obstructions; DYSPNEA; PLACEBOS; DOSAGE forms of drugs
- Publication
Respirology, 2014, Vol 19, Issue 2, p231
- ISSN
1323-7799
- Publication type
Article
- DOI
10.1111/resp.12211