European Respiratory Society

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

Anna S. Pelkonen, Kristiina Malmström, Seppo Sarna, Merja Kajosaari, Timo Klemola, L. Pekka Malmberg, Mika J. Mäkelä


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 (Vmax,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, Vmax,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.


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  • Support Statement

    Funding was provided by the Helsinki University Central Hospital Research Funds, the Sigrid Juselius Foundation and the Finnish Foundation for Allergy Research, and by an unrestricted research grant from Merck Research Laboratories (IISP ID number 33902). The funding bodies had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

  • Clinical Trial

    The study is registered at with identifier NCT00934713.

  • Statement of Interest

    Statements of interest for A.S. Pelkonen, L.P. Malmberg and M.J. Mäkelä, and for the study itself can be found at

  • Received October 6, 2011.
  • Accepted June 6, 2012.
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