title: Assessing efficacy of indacaterol in moderate and severe COPD patients: a 12-week study in an Asian population.
abstract: BACKGROUND
  This post hoc analysis evaluated the efficacy of indacaterol, a novel inhaled once-daily long-acting β(2)-agonist, by disease severity (GOLD 2005) in patients with moderate-to-severe COPD from six Asian countries/areas (Hong Kong, India, Japan, Korea, Singapore, Taiwan).
  
  
  METHODS
  Data from a 12-week, double-blind, placebo-controlled, parallel-group study in patients randomized to indacaterol 150 μg, indacaterol 300 μg or placebo once daily were analyzed based on baseline disease severity (moderate or severe). Endpoints were: trough FEV(1) (average of 23 h 10 min and 23 h 45 min post-dose values), transition dyspnoea index (TDI) and St George's Respiratory Questionnaire (SGRQ) at Week 12. Safety data were collected.
  
  
  RESULTS
  Of 347 patients randomized, 59.7% had moderate, and 40.3% had severe COPD. Least squares means (LSMs) indacaterol-placebo differences in trough FEV(1) at Week 12 exceeded the pre-specified minimal clinically important difference (MCID) of 0.12L and were statistically superior (p < 0.001) for indacaterol (150 μg, 300 μg) versus placebo in the two subgroups [0.19L, 0.20L (moderate); 0.15L, 0.19L (severe) respectively]. LSM TDI scores for both indacaterol doses versus placebo in both subgroups were statistically superior (p < 0.05) and clinically meaningful (≥1 unit). Both indacaterol doses showed improvements in LSM SGRQ total scores at Week 12 which exceeded the MCID (4 units) versus placebo in both subgroups, with indacaterol 300 μg-placebo difference in the severe subgroup being statistically significant (p < 0.01). Overall incidence of adverse events was lower with indacaterol than with placebo across both subgroups.
  
  
  CONCLUSIONS
  Indacaterol demonstrated clinically relevant improvements versus placebo in lung function, dyspnea and health status in Asian COPD patients irrespective of disease severity.
  
  
  BACKGROUND
  NCT00794157.
authors.affiliation: The Fraternity Memorial Hospital, Tokyo, Japan.
authors.forename: Yasuo
authors.initials: Y
authors.lastname: To
authors.forename: Masaharu
authors.initials: M
authors.lastname: Kinoshita
authors.forename: Sang Haak
authors.initials: SH
authors.lastname: Lee
authors.forename: Liang-Wen
authors.initials: LW
authors.lastname: Hang
authors.forename: Masakazu
authors.initials: M
authors.lastname: Ichinose
authors.forename: Yoshinosuke
authors.initials: Y
authors.lastname: Fukuchi
authors.forename: Tetsuji
authors.initials: T
authors.lastname: Kitawaki
authors.forename: Naoko
authors.initials: N
authors.lastname: Okino
authors.forename: Niyati
authors.initials: N
authors.lastname: Prasad
authors.forename: David
authors.initials: D
authors.lastname: Lawrence
authors.forename: Benjamin
authors.initials: B
authors.lastname: Kramer
mesh_terms: D000328:Adult; D000368:Aged; D001208:Asia / Q000208:ethnology; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004417:Dyspnea / Q000517:prevention & control; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006304:Health Status; D006801:Humans; D007189:Indans / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000208:ethnology; D015363:Quinolones / Q000008:administration & dosage* / Q000009:adverse effects; D012893:Sleep Wake Disorders / Q000517:prevention & control; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects
chemical_list: D001993:Bronchodilator Agents; D007189:Indans; D015363:Quinolones; C510790:indacaterol