Effects of montelukast on patients with asthma after experimental inoculation with human rhinovirus 16

Ann Allergy Asthma Immunol. 2011 Mar;106(3):252-7. doi: 10.1016/j.anai.2010.11.021. Epub 2011 Jan 13.


Background: Leukotrienes are induced by viral infections.

Objectives: To determine whether treatment with montelukast would improve asthma disease control in patients with mild allergic asthma during an experimentally induced rhinovirus infection.

Methods: Patients with mild allergic asthma were randomized to receive treatment with either montelukast or placebo, and 7 days later both groups were inoculated with human rhinovirus 16. Patients were evaluated at baseline, during the acute infection phase, and during the recovery phase for asthma and cold symptoms by questionnaire. Sputum, nasal lavage fluid, and blood were analyzed for viral shedding and cellular inflammation, and peak expiratory flow was measured daily.

Results: A total of 19 patients (11 in the placebo group and 8 in the active group) completed the study. No significant differences were found in asthma control and cold symptom scores between the control and treatment groups. The change in peak expiratory flow from the randomization to acute illness phase was greater in the placebo group than the treatment group (mean, -22 vs 0 L/min; P = .05). During the recovery phase, the percentage of sputum eosinophils increased in the placebo group and remained at baseline levels in the montelukast group (median, 2.7% vs 0.2%; P = .05 between groups).

Conclusions: In this pilot study, montelukast did not improve asthma control or cold symptom scores caused by experimental rhinovirus infection. Analysis of secondary outcomes suggests that montelukast may prevent reductions in lung function and increases in sputum eosinophils caused by common cold infections. Further studies are needed to determine whether these effects are associated with clinically significant improvements in health outcomes during natural colds.

Trial registration: clinicaltrials.gov Identifier: NCT00359073.

Publication types

  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetates / therapeutic use*
  • Asthma / drug therapy*
  • Asthma / immunology
  • Asthma / virology*
  • Common Cold / drug therapy
  • Common Cold / immunology*
  • Common Cold / virology
  • Double-Blind Method
  • Female
  • Humans
  • Leukotriene Antagonists / therapeutic use*
  • Male
  • Pilot Projects
  • Quinolines / therapeutic use*
  • RNA, Viral / chemistry
  • RNA, Viral / genetics
  • Respiratory Function Tests
  • Reverse Transcriptase Polymerase Chain Reaction
  • Rhinovirus / genetics
  • Rhinovirus / immunology*
  • Young Adult


  • Acetates
  • Leukotriene Antagonists
  • Quinolines
  • RNA, Viral
  • montelukast

Associated data

  • ClinicalTrials.gov/NCT00359073