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Original article
Oral montelukast in acute asthma exacerbations: a randomised, double-blind, placebo-controlled trial
  1. Crichton F Ramsay1,
  2. Darcy Pearson1,
  3. Sue Mildenhall1,
  4. Andrew M Wilson1,2
  1. 1Department of Respiratory Medicine, Norfolk & Norwich University Hospital, Norwich, UK
  2. 2School of Medicine Health Policy & Practice, University of East Anglia, Norwich, UK
  1. Correspondence to Dr Crichton F Ramsay, Department of Respiratory Medicine, 3rd Floor, East Wing, Norfolk & Norwich University Hospital, Colney Lane, Norwich NR4 7UY, UK; crichton.ramsay{at}


Background Although leukotriene receptor antagonists have an established role in the management of patients with chronic asthma, their efficacy in an acute asthma exacerbation is not fully known.

Methods 87 adults with acute asthma requiring hospitalisation were randomly assigned to receive either montelukast 10 mg or placebo on admission and every evening thereafter for 4 weeks (when they were reviewed as outpatients). All patients were admitted under the care of a consultant chest physician and received full care for acute asthma according to the British Thoracic Society guidelines. The primary end point was the difference in peak expiratory flow (PEF) between active and placebo treatment the morning following admission.

Results Primary end point data were analysed for 73 patients. At study entry, patients who received montelukast (n=37) had a mean (±SD) PEF of 227.6 (±56.9) l/min (47.6% predicted) and those who received placebo (n=36) had a PEF of 240.3 (±99.8) l/min (49.6% predicted). The morning after admission, patients who received montelukast achieved a PEF of 389.6 (±109.7) l/min (81.4% predicted) compared with 332.3 (±124.9) l/min (69.8% predicted) for placebo (p=0.046). The mean difference between treatment groups was 57.4 l/min (95% CI of 1.15 to 113.6 l/min or 1.95–21.2% predicted).

Conclusion In acute asthma exacerbations the additional administration of oral montelukast results in a significantly higher PEF the morning after admission than that acheivable with current standard treatment.

Clinical trial number NCT01011452.

  • Asthma/acute asthma exacerbations
  • antiasthma drugs/montelukast
  • leukotriene receptor antagonist/LTRA
  • asthma
  • asthma pharmacology

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  • Funding We are grateful for funding of £15 000 from Merck Sharp & Dohme (manufacturers of Montelukast) and £5000 from the Norfolk Association of Asthma Nurses towards the costs of this study.

  • Competing interests CFR has received educational grants towards attending international conferences and speakers fees from Merck Sharp & Dohme and has previously participated in their advisory boards. He has also previously received educational grants towards attending international conferences and speakers fees from GSK. Whilst a research registrar, part of the funding for his posts came indirectly from SmithKline Beecham and MSD. AMW is currently the principal investigator of a clinical study funded by Merck. He is also currently undertaking studies for Bayer, Schering Plough, Pharmxis and Boehringer Ingelheim. He has given talks for GSK, Merck and Astra-Zenica in the last 3 years. He undertook some consultancy work for GSK in April 2007. DP and SM have no competing interests.

  • Ethics approval This study was conducted with the approval of the Norfolk Research Ethics Committee.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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