The effect of montelukast on respiratory symptoms and lung function in wheezy infants

Eur Respir J. 2013 Mar;41(3):664-70. doi: 10.1183/09031936.00173411. Epub 2012 Jul 12.


Our aim was to investigate the effectiveness of montelukast in recurrently wheezy infants. We randomised 113, 6-24-month-old children with recurrent wheezing to receive either placebo or montelukast daily for an 8-week period. The primary end-point was symptom-free days. The secondary aims were to evaluate the effect of montelukast on rescue medication, on lung function, airway responsiveness and exhaled nitric oxide fraction (FeNO). Clinical response and FeNO were determined, the functional residual capacity (FRC) and specific airway conductance (sGaw) were measured using an infant whole-body plethysmograph, the maximal flow at functional residual capacity (V'max,FRC) was recorded using the squeeze technique and airway responsiveness was evaluated by performing a dosimetric methacholine challenge test. There was no significant difference in changes in weekly symptom-free days between the montelukast and the placebo group (3.1-3.7 days versus 2.7-3.1 days, p = 0.965). No significant differences were detected in the secondary end-points, i.e. use of rescue medication, FRC, sGaw, V'max,FRC, FeNO or airway responsiveness between groups. Montelukast therapy did not influence the number of symptom-free days, use of rescue medication, lung function, airway responsiveness or airway inflammation in recurrently wheezy, very young children.

Trial registration: NCT00934713.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acetates / pharmacology*
  • Anti-Asthmatic Agents / pharmacology*
  • Bronchial Provocation Tests
  • Child, Preschool
  • Cyclopropanes
  • Female
  • Humans
  • Infant
  • Inflammation / physiopathology
  • Lung / drug effects*
  • Lung / pathology
  • Male
  • Nitric Oxide / metabolism
  • Plethysmography
  • Quinolines / pharmacology*
  • Respiration / drug effects*
  • Respiratory Function Tests
  • Respiratory Sounds / drug effects*
  • Sulfides
  • Treatment Outcome


  • Acetates
  • Anti-Asthmatic Agents
  • Cyclopropanes
  • Quinolines
  • Sulfides
  • Nitric Oxide
  • montelukast

Associated data