title: Effectiveness of montelukast administered as monotherapy or in combination with inhaled corticosteroid in pediatric patients with uncontrolled asthma: a prospective cohort study.
abstract: BACKGROUND
  Asthma is the most common chronic disease of childhood and a leading cause of childhood morbidity. The aim of the current study was to assess the effectiveness of montelukast administered as monotherapy or in combination with current inhaled corticosteroids (ICS) in pediatric patients with uncontrolled asthma as per the Canadian Asthma Consensus Guidelines.
  
  
  METHODS
  Twelve-week, multicentre, open-label, observational study. Primary effectiveness outcome was the proportion of patients achieving asthma control (Asthma Control Questionnaire (ACQ) score ≤0.75) at weeks 4 and 12.
  
  
  RESULTS
  A total of 328 patients with uncontrolled asthma (ACQ > 0.75) were enrolled with mean ± SD age of 6.9 ± 3.4 years. Among these, 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 the patients in the monotherapy and combination group, respectively, achieved asthma control. These proportions increased to 75.0% and 70.9%, respectively, at 12 weeks. Within the monotherapy group, clinically significant improvements in the ACQ score (mean ± SD of 1.67 ± 0.69, 0.71 ± 0.70 and 0.50 ± 0.52 at baseline, 4 and 12 weeks, respectively; p < 0.001) and the PACQLQ score (mean ± SD of 5.34 ± 1.14, 6.32 ± 0.89 and 6.51 ± 0.85 at baseline, 4 and 12 weeks, respectively; p < 0.001) were observed. In the combination group, the mean ± SD ACQ score significantly improved from 2.02 ± 0.83 at baseline to 0.90 ± 0.86 at 4 weeks and 0.64 ± 0.86 at 12 weeks (p < 0.001), while the PACQLQ score improved from 4.42 ± 1.35 at baseline to 5.76 ± 1.30 at 4 weeks and 6.21 ± 1.03 at 12 weeks (p < 0.001). After a 12-week montelukast add-on therapy, 22.6% of patients reduced their ICS dosage. Similar results were observed among preschool- and school-aged patients.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  This study is registered at ClinicalTrial.gov: NCT00832455.
authors.affiliation: CHU Ste-Justine, Université de Montréal, Montréal, Québec, Canada.
authors.forename: Denis
authors.initials: D
authors.lastname: Bérubé
authors.affiliation: Merck Canada Inc., Kirkland, Québec, Canada ; Current address: Novartis Canada, Dorval, Québec, Canada.
authors.forename: Michel
authors.initials: M
authors.lastname: Djandji
authors.affiliation: McGill University, Montréal, Québec, Canada ; JSS Medical Research, Montréal, Québec, Canada.
authors.forename: John S
authors.initials: JS
authors.lastname: Sampalis
authors.affiliation: Section of Allergy and Clinical Immunology, Department of Pediatrics and Child Health, University of Manitoba, Manitoba, Canada.
authors.forename: Allan
authors.initials: A
authors.lastname: Becker
keywords: Asthma; Inhaled corticosteroids; Montelukast; Pediatric; Preschool age; School age