Volume 10 Supplement 1

Canadian Society of Allergy and Clinical Immunology Annual Scientific Meeting 2013

Open Access

Real-life effectiveness of montelukast administered as monotherapy or in combination with inhaled corticosteroid (ICS) in pediatric patients with uncontrolled asthma

  • Denis Bérubé1,
  • Michel Djandji2,
  • John S Sampalis3, 4Email author and
  • Allan Becker5
Allergy, Asthma & Clinical Immunology201410(Suppl 1):A55


Published: 3 March 2014


The efficacy of montelukast in the treatment of asthma has been demonstrated in numerous controlled clinical trials. The aim of this study was to assess the real-life effectiveness of montelukast administered as monotherapy or in combination with current ICS in children with uncontrolled asthma.


Twelve-week open-label, phase IV, multicenter, prospective cohort study. Eligible patients included children aged 2-14 years diagnosed with asthma for =6 months who were: (i) uncontrolled as per the Canadian Asthma Consensus Guidelines, and; (ii) either untreated, using a short-acting ß2–agonist as-needed or using any dose ICS. In this analysis, patients with Asthma Control Questionnaire (ACQ) score >0.75 were included. Patients 6-14 and 2-5.9 years old were treated once-daily with montelukast 5mg and 4mg, respectively. Primary outcome measure was the proportion achieving asthma control (ACQ=0.75). Secondary outcomes were the absolute change in ACQ and in the Pediatric Asthma Caregiver’s Quality of Life Questionnaire (PACQLQ) over time.


Among the 328 patients included, 76 (23.2%) were treated with montelukast monotherapy and 252 (76.8%) with montelukast combined with ICS. By 4 weeks of treatment 61.3% and 52.9% of patients in the monotherapy and combination group, respectively, achieved asthma control. These proportions increased to 75.0% and 70.9%, respectively, at week-12. Clinically and statistically (P<0.001) significant improvements were observed in ACQ (monotherapy: mean (SD) of 1.67 (0.69) at baseline and 0.50 (0.52) at week-12; combination therapy: 2.02 (0.83) and 0.64 (0.86), respectively) and PACQLQ (monotherapy: mean (SD) of 5.34 (1.14) at baseline and 6.51 (0.85) at week-12; combination therapy: 4.42 (1.35) and 6.21 (1.03), respectively) in both patient subgroups. After a 12-week montelukast add-on therapy, 22.6% of patients reduced their ICS dosage.


Montelukast as monotherapy or in combination with ICS represents an effective treatment strategy for achieving asthma control in pediatric patients and improving caregivers’ quality of life.


On behalf of the ACTION3 investigators.

Trial registration

Clinicaltrials.gov: 00832455.

Authors’ Affiliations

Centre Hospitalier Universitaire (CHU) Sainte-Justine, Université de Montréal
Merck Canada Inc.
McGill University
JSS Medical Research
Section of Allergy and Clinical Immunology, Department of Pediatrics and Child Health, University of Manitoba


© Sampalis et al; licensee BioMed Central Ltd. 2014

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.