title: Long-term safety and efficacy of indacaterol, a long-acting β₂-agonist, in subjects with COPD: a randomized, placebo-controlled study.
abstract: BACKGROUND
  Indacaterol is an inhaled, long-acting β(2)-agonist providing 24-h bronchodilation with once-daily dosing in patients with COPD.
  
  
  METHODS
  Subjects with moderate to severe COPD who completed a 26-week, randomized, double-blind study were eligible for enrollment in an extension, during which treatment with double-blind indacaterol, 150 or 300 μg once daily, or placebo was continued for a further 26 weeks. The primary objective was to evaluate the long-term safety of indacaterol. Efficacy end points included trough (24 h postdose) FEV(1) at 52 weeks, exacerbations, and health status (St. George Respiratory Questionnaire [SGRQ]).
  
  
  RESULTS
  Four hundred fifteen subjects participated in the extension. Adverse events, mostly mild or moderate, occurred in 76%, 77%, and 68% of subjects receiving indacaterol, 150 μg; indacaterol, 300 μg; and placebo, respectively. Serious adverse events occurred in 10.4%, 12.3%, and 10.5%, respectively. Indacaterol had no clinically significant effects on ECG findings (corrected QT interval) or on serum potassium or plasma glucose levels. Indacaterol increased trough FEV(1) relative to placebo throughout the study (difference of ≥ 170 mL at week 52). No tolerance to its bronchodilator effect was detected. Indacaterol treatment was accompanied by significant reductions in COPD exacerbations (rate ratios compared with placebo, 0.62-0.64; P < .05) and as-needed albuterol use (1.2-1.4 puffs/d decrease, P < .001 compared with placebo). Health status improved with indacaterol treatment, with decreases from baseline in mean total SGRQ score generally > 4 units.
  
  
  CONCLUSIONS
  During 1 year of treatment, indacaterol was well tolerated and provided significant and well-maintained bronchodilation that was accompanied by improved clinical outcomes.
  
  
  BACKGROUND
  ClinicalTrials.gov; No.: NCT00677807; URL: www.clinicaltrials.gov.
authors.affiliation: Asthma and Airway Centre, University Health Network, Toronto Western Hospital, Toronto, ON, Canada; Department of Medicine, University of Toronto, Toronto, ON, Canada. Electronic address: kchapman@ca.inter.net.
authors.forename: Kenneth R
authors.initials: KR
authors.lastname: Chapman
authors.affiliation: Department of Pulmonary Critical Care, Allergy and Sleep Medicine, University of Nebraska Medical Center, Omaha, NE.
authors.forename: Stephen I
authors.initials: SI
authors.lastname: Rennard
authors.affiliation: Novartis Pharmaceuticals, East Hanover, NJ.
authors.forename: Angeli
authors.initials: A
authors.lastname: Dogra
authors.affiliation: Novartis Horsham Research Centre, Horsham, West Sussex, England.
authors.forename: Roger
authors.initials: R
authors.lastname: Owen
authors.affiliation: Novartis Horsham Research Centre, Horsham, West Sussex, England.
authors.forename: Cheryl
authors.initials: C
authors.lastname: Lassen
authors.affiliation: Novartis Pharmaceuticals, East Hanover, NJ.
authors.forename: Benjamin
authors.initials: B
authors.lastname: Kramer
mesh_terms: D000280:Administration, Inhalation; D000284:Administration, Oral; D016084:Bronchoconstriction / Q000187:drug effects*; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D005540:Forced Expiratory Flow Rates / Q000187:drug effects / Q000502:physiology*; 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*; D012074:Remission Induction; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D003692:Delayed-Action Preparations; D007189:Indans; D015363:Quinolones; C510790:indacaterol