title: Effect of once-daily indacaterol maleate/mometasone furoate on exacerbation risk in adolescent and adult asthma: a double-blind randomised controlled trial.
abstract: OBJECTIVE
  To investigate the safety and efficacy of QMF149, a once-daily, fixed-dose combination of the long-acting β2-agonist (LABA) indacaterol maleate and inhaled corticosteroid (ICS) mometasone furoate (MF) for the treatment of persistent asthma. The hypothesis was that QMF149 would not increase the risk of serious asthma exacerbations.
  
  
  METHODS
  174 research centres in nine countries.
  
  
  METHODS
  1519 adolescents and adults with persistent asthma who were treated or qualified for treatment with combination LABA/ICS were randomised, and 1508 were included in the intention-to-treat analysis.
  
  
  METHODS
  Patients were randomised to QMF149 (indacaterol maleate 500 µg/MF 400 µg) or MF (400 µg) once daily via Twisthaler inhalation device in a double-blind, parallel-group study for 6-21 months.
  
  
  METHODS
  The primary end point was time to first serious asthma exacerbation (resulting in hospitalisation, intubation or death). The key secondary end point was annual rate of exacerbations requiring systemic corticosteroids.
  
  
  RESULTS
  Treatment with QMF149 resulted in no significant difference in time to first serious exacerbation compared to MF (2 (0.3%) vs 6 events (0.8%); difference -0.52 percentage point; 95% CI -1.25 to 0.21, p=0.160, HR=0.31; 95% CI 0.06 to 1.54, p=0.151). QMF149 significantly reduced the annual rate of exacerbations requiring systemic corticosteroids (rate ratio=0.71; 95% CI 0.55 to 0.90, p=0.005). Proportions of patients experiencing adverse events were similar across groups (74.0% in the QMF149 group and 73.4% in the MF group). Serious adverse events occurred in 4% and 5.8% of patients in the QMF149 and MF groups, respectively.
  
  
  CONCLUSIONS
  No significant difference was observed in the primary outcome of time to first serious asthma exacerbation in patients treated with QMF149 compared with patients treated with MF. Long-term treatment with QMF149 once daily had a favourable safety/efficacy profile in adolescent and adult patients with persistent asthma.
  
  
  BACKGROUND
  ClinicalTrials.gov; NCT00941798.
authors: Medical Research Institute of New Zealand, Wellington, New Zealand.
authors: Richard W
authors: RW
authors: Beasley
authors: Department of Medicine, University of North Carolina, Chapel Hill, North Carolina, USA.
authors: James F
authors: JF
authors: Donohue
authors: Dr Mehta's Allergy & Asthma Care and Research Center, Indore, Madhya Pradesh, India.
authors: Rajendra
authors: R
authors: Mehta
authors: National Jewish Health, Denver, Colorado, USA.
authors: Harold S
authors: HS
authors: Nelson
authors: Novartis Horsham Research Centre, Horsham, West Sussex, UK.
authors: Michelle
authors: M
authors: Clay
authors: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors: Allen
authors: A
authors: Moton
authors: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey, USA.
authors: Han-Joo
authors: HJ
authors: Kim
authors: Novartis Pharmaceuticals Corporation, Basel, Switzerland.
authors: Bettina M
authors: BM
authors: Hederer
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000494:pharmacology / Q000627:therapeutic use*; D000318:Adrenergic beta-Agonists / Q000494:pharmacology / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000494:pharmacology / Q000627:therapeutic use; D018927:Anti-Asthmatic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy*; D018450:Disease Progression; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007189:Indans / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D008298:Maleates / Q000494:pharmacology / Q000627:therapeutic use*; D008875:Middle Aged; D000068656:Mometasone Furoate; D011244:Pregnadienediols / Q000494:pharmacology / Q000627:therapeutic use*; D015363:Quinolones / Q000494:pharmacology / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D000318:Adrenergic beta-Agonists; D018926:Anti-Allergic Agents; D018927:Anti-Asthmatic Agents; D007189:Indans; D008298:Maleates; D011244:Pregnadienediols; D015363:Quinolones; D000068656:Mometasone Furoate; C510790:indacaterol
keywords: CLINICAL PHARMACOLOGY
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