title: Indacaterol once-daily is equally effective dosed in the evening or morning in COPD.
abstract: Indacaterol is a novel, inhaled, long-acting β(2)-agonist providing 24-h bronchodilation with once-daily (o.d.) dosing in patients with COPD. In this double-blind, incomplete block crossover study, patients with moderate-to-severe COPD were randomised to receive three treatment cycles from: indacaterol 300 μg o.d. dosed PM or AM, salmeterol 50 μg twice daily or placebo, each for 14 days. Trough FEV(1) was measured 24 h after indacaterol, and 12 h after salmeterol. Ninety-six patients (mean age: 64 years; post-bronchodilator FEV(1) 57% predicted, FEV(1)/FVC 55%) were randomised; 83 completed. After 14 days, the difference vs. placebo in trough FEV(1) for PM indacaterol was 200 mL (p < 0.001 [primary analysis]) and for AM indacaterol was 200 mL (p < 0.001). Compared with salmeterol, trough FEV(1) for PM indacaterol was 110 mL higher (p < 0.001), and for AM indacaterol was 50 mL higher (p = NS). Over 14 days, vs. placebo, both PM and AM indacaterol improved the % of nights with no awakenings (by 11.9 and 8.1 points; p < 0.01); the % of days with no daytime symptoms (by 6.7 and 5.5 points; p < 0.05); and the % of days able to perform usual activities (by 6.7 and 7.8 points; p < 0.05). Indacaterol provided 24-h bronchodilation and improvement in symptoms regardless of whether taken regularly in the morning or evening.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT00615030.
authors.affiliation: Pulmonary Research Institute, Hospital Grosshansdorf, Grosshansdorf, Germany.
authors.forename: H
authors.initials: H
authors.lastname: Magnussen
authors.forename: C
authors.initials: C
authors.lastname: Verkindre
authors.forename: D
authors.initials: D
authors.lastname: Jack
authors.forename: D
authors.initials: D
authors.lastname: Jadayel
authors.forename: M
authors.initials: M
authors.lastname: Henley
authors.forename: R
authors.initials: R
authors.lastname: Woessner
authors.forename: M
authors.initials: M
authors.lastname: Higgins
authors.forename: B
authors.initials: B
authors.lastname: Kramer
mesh_terms: D000280:Administration, Inhalation; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage*; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007189:Indans / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D015363:Quinolones / Q000008:administration & dosage*; D013997:Time Factors
chemical_list: D000318:Adrenergic beta-Agonists; D007189:Indans; D015363:Quinolones; C510790:indacaterol