title: Efficacy and safety of indacaterol 150 and 300 µg in chronic obstructive pulmonary disease patients from six Asian areas including Japan: a 12-week, placebo-controlled study.
abstract: OBJECTIVE
  The efficacy and safety of indacaterol, a novel inhaled once daily ultra long-acting β(2) -agonist was evaluated in COPD patients in six Asian countries/areas. This study was primarily designed to obtain the regulatory approval of indacaterol in Japan.
  
  
  METHODS
  Moderate-to-severe COPD patients were randomized to indacaterol 150 µg, indacaterol 300 µg or placebo once daily. Efficacy variables: trough FEV(1) (average of 23 h 10 min and 23 h 45 min post-dose values), health status (St. George's Respiratory Questionnaire) and transition dyspnoea index at week 12. Safety/tolerability was evaluated.
  
  
  RESULTS
  A total of 347 patients were randomized (96.5% male, mean (SD) age 66.7 (8.38) years, post-bronchodilator FEV(1) % predicted: 53.7 (12.50)); 88.8% completed. The least squares means (LSM) trough FEV(1) at week 12 for indacaterol 150 µg, indacaterol 300 µg and placebo were 1.34 L, 1.37 L and 1.17 L, respectively, with differences versus placebo exceeding the prespecified minimal clinically important difference of 0.12 L (0.17 L and 0.20 L for indacaterol 150 µg and 300 µg, respectively, both P < 0.001). The week 12 LSM transition dyspnoea index score was statistically superior for both indacaterol doses versus placebo (differences of 1.30 and 1.26, P < 0.001; both exceeding the minimal clinically important difference of 1). At week 12, both indacaterol doses provided statistically significant (P ≤ 0.005) and clinically meaningful (≥4 units) improvements in LSM St. George's Respiratory Questionnaire total score versus placebo (differences: -4.8 and -5.7 units). Adverse events for indacaterol (49.1%, both doses) were lower than placebo (59.0%) and were mostly mild/moderate in severity; no deaths were reported.
  
  
  CONCLUSIONS
  Indacaterol provided clinically significant bronchodilation and improvements in dyspnoea and health status in Asian COPD patients.
authors: Nagata Hospital, Fukuoka, Japan.
authors: Masaharu
authors: M
authors: Kinoshita
authors: Sang Haak
authors: SH
authors: Lee
authors: Liang-Wen
authors: LW
authors: Hang
authors: Masakazu
authors: M
authors: Ichinose
authors: Motoi
authors: M
authors: Hosoe
authors: Naoko
authors: N
authors: Okino
authors: Niyati
authors: N
authors: Prasad
authors: Benjamin
authors: B
authors: Kramer
authors: Yoshinosuke
authors: Y
authors: Fukuchi
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D016084:Bronchoconstriction / Q000187:drug effects*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005541:Forced Expiratory Volume / Q000187:drug effects; D006723:Hong Kong / Q000453:epidemiology; D006801:Humans; D007189:Indans / Q000008:administration & dosage* / Q000627:therapeutic use; D007194:India / Q000453:epidemiology; D007564:Japan / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D015363:Quinolones / Q000008:administration & dosage* / Q000627:therapeutic use; D056910:Republic of Korea / Q000453:epidemiology; D012189:Retrospective Studies; D012846:Singapore / Q000453:epidemiology; D011795:Surveys and Questionnaires; D013624:Taiwan / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007189:Indans; D015363:Quinolones; C510790:indacaterol