title: Indacaterol therapy in patients with COPD not receiving other maintenance treatment.
abstract: BACKGROUND
  Recent findings of rapid lung function decline in younger patients with moderate COPD severity suggest the need for effective early treatment.
  
  
  OBJECTIVE
  To evaluate the effectiveness of indacaterol as maintenance therapy in COPD patients not receiving other maintenance treatments.
  
  
  METHODS
  Pooled data from three randomised, placebo-controlled studies provided a population of patients with moderate-to-severe COPD not receiving maintenance treatment at baseline and who received once-daily, double-blind treatment with indacaterol 150 μg, indacaterol 300 μg or placebo. Data from an open-label tiotropium treatment arm in one study were available for comparison. Efficacy evaluations included trough FEV₁, dyspnoea (transition dyspnoea index, TDI) and health status (St George's Respiratory Questionnaire, SGRQ) at 6 months and risk of COPD exacerbations.
  
  
  RESULTS
  The maintenance-naïve population comprised 232 (indacaterol 150 μg), 220 (indacaterol 300 μg) and 325 (placebo) patients, plus 156 (tiotropium) (30% of overall study population). Patients treated with indacaterol 150 and 300 μg had statistically significant improvements relative to placebo (p < 0.05) in trough FEV₁ (170 and 180 mL), TDI total score (1.27 and 1.04 points), rescue use and SGRQ total score (-6.1 and -2.5 units) at 6 months. Patients receiving tiotropium had statistically significant improvements versus placebo (p < 0.05) in trough FEV₁ (130 mL) and TDI total score (0.69 points). Exacerbations were rare and not significantly reduced by any treatment. Treatments were well tolerated.
  
  
  CONCLUSIONS
  Indacaterol, given to patients with moderate-to-severe COPD not receiving other maintenance treatments, provided effective bronchodilation with significant, clinically relevant improvements in dyspnoea and health status compared with placebo.
authors.affiliation: Respiratory Division, University Hospitals, Chief Respiratory Division UZ Leuven, Campus Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium. Marc.Decramer@uzleuven.be
authors.forename: Marc
authors.initials: M
authors.lastname: Decramer
authors.forename: Andrea
authors.initials: A
authors.lastname: Rossi
authors.forename: David
authors.initials: D
authors.lastname: Lawrence
authors.forename: Danny
authors.initials: D
authors.lastname: McBryan
mesh_terms: D001993:Bronchodilator Agents / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007189:Indans / Q000627:therapeutic use*; D060046:Maintenance Chemotherapy / Q000379:methods; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D015363:Quinolones / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects
chemical_list: D001993:Bronchodilator Agents; D007189:Indans; D015363:Quinolones; C510790:indacaterol