title: Effect of QVA149 on lung volumes and exercise tolerance in COPD patients: the BRIGHT study.
abstract: BACKGROUND
  QVA149 is a novel, inhaled, once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium (NVA237), for the treatment of chronic obstructive pulmonary disease (COPD). This study evaluated the effects of QVA149 on exercise tolerance, hyperinflation, lung function and lung volumes versus placebo and tiotropium.
  
  
  METHODS
  Patients with moderate-to-severe COPD were randomized to QVA149 110/50 μg, placebo or tiotropium 18 μg once daily in a blinded, 3-period crossover study for 3 weeks. The primary endpoint was exercise endurance time at Day 21 for QVA149 versus placebo.
  
  
  RESULTS
  Eighty-five patients were randomized; 86% completed the study. QVA149 significantly improved exercise endurance time at Day 21 compared with placebo (least squares mean treatment difference 60 s [p = 0.006]). No significant improvements in exercise endurance time at Day 21 between QVA149 and tiotropium were found. Dynamic inspiratory capacity (IC) at exercise isotime, trough forced expiratory volume in 1 s, residual volume and functional residual capacity showed significant improvements with QVA149 from Day 1 of treatment that were maintained throughout the study. The safety profiles were similar across groups.
  
  
  CONCLUSIONS
  In patients with moderate-to-severe COPD, once-daily QVA149 significantly improved exercise endurance time compared with placebo which was associated with sustained reductions of lung hyperinflation as indicated by significant improvement in IC at rest and during exercise.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01294787.
  
  
  CONCLUSIONS
  Dual bronchodilation with QVA149 decreases lung hyperinflation and improves exercise tolerance and lung function in patients with moderate-to-severe COPD.
authors.affiliation: insaf Respiratory Research Institute, Wiesbaden, Germany. Electronic address: k.beeh@insaf-wi.de.
authors.forename: Kai-Michael
authors.initials: KM
authors.lastname: Beeh
authors.affiliation: Pulmonary Department, Mainz University Hospital, Mainz, Germany.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Korn
authors.affiliation: insaf Respiratory Research Institute, Wiesbaden, Germany.
authors.forename: Jutta
authors.initials: J
authors.lastname: Beier
authors.affiliation: Novartis Horsham Research Center, Horsham, UK.
authors.forename: Dalal
authors.initials: D
authors.lastname: Jadayel
authors.affiliation: Novartis Horsham Research Center, Horsham, UK.
authors.forename: Michelle
authors.initials: M
authors.lastname: Henley
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: Peter
authors.initials: P
authors.lastname: D'Andrea
authors.affiliation: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors.forename: Donald
authors.initials: D
authors.lastname: Banerji
mesh_terms: D000328:Adult; D000368:Aged; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004338:Drug Combinations; D017079:Exercise Tolerance / Q000187:drug effects; D005260:Female; D005541:Forced Expiratory Volume / Q000187:drug effects; D006024:Glycopyrrolate / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D007189:Indans / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008176:Lung Volume Measurements; D008297:Male; D008875:Middle Aged; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy* / Q000503:physiopathology; D015363:Quinolones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012602:Scopolamine Derivatives / Q000627:therapeutic use; D013147:Spirometry / Q000379:methods; D000069447:Tiotropium Bromide; D016896:Treatment Outcome; D014797:Vital Capacity / Q000187:drug effects
chemical_list: D001993:Bronchodilator Agents; D004338:Drug Combinations; D007189:Indans; D015363:Quinolones; D012602:Scopolamine Derivatives; C554862:indacaterol-glycopyrronium combination; D006024:Glycopyrrolate; D000069447:Tiotropium Bromide
keywords: Chronic obstructive pulmonary disease; Exercise; Hyperinflation; QVA149; Tiotropium