title: Effect of once-daily indacaterol in a predominantly Chinese population with chronic obstructive pulmonary disease: a 26-week Asia-Pacific study.
abstract: 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.affiliation: Peking University Third Hospital, Beijing, China.
authors.forename: Wanzhen
authors.initials: W
authors.lastname: Yao
authors.affiliation: Xingiao Hospital, Third Military Medical University, Chongqing, China.
authors.forename: Changzheng
authors.initials: C
authors.lastname: Wang
authors.affiliation: Guangzhou Institute of Respiratory Disease, Guangzhou, China.
authors.forename: Nanshan
authors.initials: N
authors.lastname: Zhong
authors.affiliation: People's Hospital of Hebei Province, Shi Jia Zhuang, China.
authors.forename: Xiaowen
authors.initials: X
authors.lastname: Han
authors.affiliation: Department of Respiratory Medicine, Xijing Hospital, Xi'an, China.
authors.forename: Changgui
authors.initials: C
authors.lastname: Wu
authors.affiliation: The Second Hospital of Hebei Medical University, Shi Jia Zhuang, China.
authors.forename: Xixin
authors.initials: X
authors.lastname: Yan
authors.affiliation: The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.
authors.forename: Ping
authors.initials: P
authors.lastname: Chen
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors.forename: Wei
authors.initials: W
authors.lastname: Yang
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors.forename: Michelle
authors.initials: M
authors.lastname: Henley
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Kramer
mesh_terms: D000368:Aged; D002681:China / Q000453:epidemiology; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume / Q000187:drug effects; D006304:Health Status; D006801:Humans; D015994:Incidence; D007189:Indans / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D015363:Quinolones / Q000008:administration & dosage*; D011795:Surveys and Questionnaires; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007189:Indans; D015363:Quinolones; C510790:indacaterol
keywords: Chinese; chronic obstructive pulmonary disease; efficacy; indacaterol; safety