|Effect of once-daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: A 26-week Asia-Pacific study|
|Yao, Wanzhen1; Wang, Changzheng2; Zhong, Nanshan3; Han, Xiaowen4; Wu, Changgui6; Yan, Xixin5; Chen, Ping7; Yang, Wei8; Henley, Michelle8; Kramer, Benjamin8|
|关键词||Chinese chronic obstructive pulmonary disease efficacy indacaterol safety|
|WOS标题词||Science & Technology|
|关键词[WOS]||AIR-FLOW OBSTRUCTION ; LUNG HYPERINFLATION ; DOUBLE-BLIND ; COPD ; EXERCISE ; EFFICACY ; BRONCHODILATORS ; SALMETEROL ; TIOTROPIUM ; TRIAL|
Background and objectiveThis study, in a predominantly Chinese population, investigated the efficacy and safety of a once-daily (o.d.) inhaled ultra-long-acting (2)-agonist indacaterol for the treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD).
MethodsThis is a 26-week, double-blind study on randomized patients who received indacaterol 150g or 300g or placebo o.d. The primary variable was trough forced expiratory volume in 1s (FEV1, average of 23h 10min and 23h 45min 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.
ResultsOf the 563 patients randomized, 561 (89.8% Chinese) received treatment and 482 completed. At Week 12, trough FEV1 improved significantly for indacaterol 150 and 300g 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 0.12L. At Week 26, TDI score was superior to placebo for indacaterol 150 and 300g (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.
ConclusionsIndacaterol delivered effective bronchodilation with significant improvements in breathlessness and health status in this predominantly Chinese population.
We investigated the effect of indacaterol on FEV1, dyspnoea and health-related quality of life in a predominantly Chinese population diagnosed with moderate-to-severe COPD. Indacaterol proved to be a useful treatment option as it showed effective bronchodilation and improvements in breathlessness and health status in this population.
|资助机构||Novartis Pharma AG, Basel, Switzerland|
|作者单位||1.Peking Univ, Hosp 3, Beijing 100083, Peoples R China|
2.Guangzhou Inst Resp Dis, Guangzhou, Guangdong, Peoples R China
3.Peoples Hosp Hebei Prov, Shijiazhuang, Peoples R China
4.Hebei Med Univ, Hosp 2, Shijiazhuang, Peoples R China
5.Xijing Hosp, Dept Resp Med, Xian, Peoples R China
6.Novartis Pharmaceut, E Hanover, NJ USA
7.Third Mil Med Univ, Xingiao Hosp, Chongqing, Peoples R China
8.Cent S Univ, Xiangya Hosp 2, Changsha, Hunan, Peoples R China
|Yao, Wanzhen,Wang, Changzheng,Zhong, Nanshan,et al. Effect of once-daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: A 26-week Asia-Pacific study[J]. RESPIROLOGY,2014,19(2):231-238.|
|APA||Yao, Wanzhen.,Wang, Changzheng.,Zhong, Nanshan.,Han, Xiaowen.,Wu, Changgui.,...&Kramer, Benjamin.(2014).Effect of once-daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: A 26-week Asia-Pacific study.RESPIROLOGY,19(2),231-238.|
|MLA||Yao, Wanzhen,et al."Effect of once-daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: A 26-week Asia-Pacific study".RESPIROLOGY 19.2(2014):231-238.|