title: Montelukast for Children with Obstructive Sleep Apnea: Results of a Double-Blind, Randomized, Placebo-Controlled Trial.
abstract: Obstructive sleep apnea (OSA) is highly prevalent in children and is usually treated by adenotonsillectomy. Nonsurgical therapies for OSA consist primarily of antiinflammatory approaches and have gained popularity, but their efficacy remains to be critically examined.
  
  
  
  To determine the effect of montelukast on pediatric OSA.
  
  
  
  A prospective randomized double-blind controlled trial of polysomnographically diagnosed OSA in children ages 2-10 years who were treated with either oral montelukast (4 or 5 mg daily) or placebo for 16 weeks. Adherence to the medication was ascertained using automated timed pill dispensers along with weekly telephonic reminders.
  
  
  
  Ninety-two children diagnosed with OSA were approached, and 64 (69.6%) agreed to participate. Of these, 57 (89.0%) completed the 16-week trial, 28 in the montelukast group and 29 in the placebo group. Age, sex, and percentage of obesity were similar in the two groups, as were initial apnea-hypopnea index (AHI) scores. Overall, intention-to-treat analyses revealed that beneficial effects occurred in 20 children receiving montelukast (71.4%), whereas only 2 (6.9%) of the children receiving placebo showed reductions in AHI score (P < 0.001). Indeed, AHI decreased from 9.2 ± 4.1/hour total sleep time (TST) to 4.2 ± 2.8/hour TST (P < 0.0001) in montelukast-treated children, whereas in children receiving placebo, the AHI did not change (from 8.2 ± 5.0/h TST before to 8.7 ± 4.9/h TST at completion of the trial).
  
  
  
  When compared with placebo, montelukast for 16 weeks effectively reduced the severity of obstructive sleep apnea in children 2-10 years of age. These results support a therapeutic role for leukotriene modifiers in pediatric OSA provided that long-term trials confirm current findings. Clinical trial registered with www.clinicaltrials.gov (NCT 00599534).
authors.affiliation: Section of Pediatric Sleep Medicine, Department of Pediatrics, Biological Sciences Division, Pritzker School of Medicine, University of Chicago, Chicago, Illinois.
authors.forename: Leila
authors.identifier: 0000-0003-3332-1057
authors.initials: L
authors.lastname: Kheirandish-Gozal
authors.affiliation: Section of Pediatric Sleep Medicine, Department of Pediatrics, Biological Sciences Division, Pritzker School of Medicine, University of Chicago, Chicago, Illinois.
authors.forename: Hari P R
authors.initials: HP
authors.lastname: Bandla
authors.affiliation: Section of Pediatric Sleep Medicine, Department of Pediatrics, Biological Sciences Division, Pritzker School of Medicine, University of Chicago, Chicago, Illinois.
authors.forename: David
authors.identifier: 0000-0001-8195-6036
authors.initials: D
authors.lastname: Gozal
mesh_terms: D000085:Acetates / Q000008:administration & dosage*; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage*; D002648:Child; D002675:Child, Preschool; D003521:Cyclopropanes; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007629:Kentucky; D020024:Leukotriene Antagonists / Q000008:administration & dosage*; D008297:Male; D014066:Palatine Tonsil / Q000503:physiopathology / Q000601:surgery; D017286:Polysomnography; D011446:Prospective Studies; D011804:Quinolines / Q000008:administration & dosage*; D020181:Sleep Apnea, Obstructive / Q000628:therapy*; D013440:Sulfides
chemical_list: D000085:Acetates; D000893:Anti-Inflammatory Agents; D003521:Cyclopropanes; D020024:Leukotriene Antagonists; D011804:Quinolines; D013440:Sulfides; C093875:montelukast
keywords: adenotonsillar hypertrophy; inflammation; leukotrienes; obstructive sleep apnea; tonsils