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Randomised controlled trial
Montelukast potentially efficacious in children with non-severe obstructive sleep apnoea in the short term
  1. Joanna E MacLean
  1. Department of Pediatrics, University of Alberta, Edmonton, Canada
  1. Correspondence to : Joanna E MacLean
    Department of Pediatrics, University of Alberta, 4–590 Edmonton Clinic Health Academy, 11415 87th Avenue NW, Edmonton, Alberta, Canada T6G 1C9; joanna.maclean{at}

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Obstructive sleep apnoea (OSA) is a common condition affecting 1–5% of children. The most common cause of OSA in childhood is adenotonsillar hypertrophy which is mediated by inflammation. While anti-inflammatory therapy is commonly trialled as a treatment strategy in mild forms, there is a paucity of literature to support this treatment strategy for children with OSA.


This study by Goldbart and colleagues was conducted in a single tertiary care centre in a metropolitan area. This is a double-blind randomised placebo-controlled trial of montelukast for the treatment of non-severe OSA in children. The population for recruitment was children referred for evaluation of snoring. Subjects were 2–10 years of age, had habitual snoring, non-severe OSA (defined as an apnoea/hypopnoea index <10 events/h) and were naïve to montelukast therapy as well as adenotonsillectomy. Children were excluded if they were obese; had craniofacial, neuromuscular, syndromic or genetic abnormalities; acute upper respiratory tract infection; or had used steroids and/or antibiotics in the 4 weeks preceding enrolment. Block randomisation was used to assign 46 of 50 consecutively eligible children to the treatment (n=23) and control (n=23) groups.

Children received 12 weeks of treatment. Montelukast was dosed by age: children <6 years received 4 mg/day and children >6 years receiving 5 mg/day. Placebo tablets were identical to the active treatment. Investigators were blind to treatment allocation and the pharmacist dispensing treatment was blind to the subject details.

Outcome measures included polysomnography and lateral neck radiograph at baseline and at the end of the 12-week treatment period. The investigators performing the measurements of adenoidal/nasopharyngeal ratio on lateral neck radiographs were blind to polysomnography findings. A sleep questionnaire of symptoms was also administered, though details of this questionnaire are not provided.


The subject groups were well matched for age and gender at baseline. Children receiving montelukast showed significant improvement in the obstructive apnoea index (3.9±1.6 events/h before vs 1.7±1.0 events/h after treatment) and a decrease in adenoidal/nasopharygeal ratio (0.81±0.004 before vs 0.57±0.004 after treatment) after 12 weeks of therapy. By contrast, children receiving no active treatment showed no change on the same parameters (p<0.05 and 0.01, respectively). Neither group showed change in sleep parameters or oxygenation indices. Significant improvements of OSA symptoms were seen in children receiving montelukast with no symptom improvement in the placebo group. No adverse events were reported by parents during the study period.


Anti-inflammatory therapy has been proposed as an alternative to surgical treatment for children with mild obstructive sleep apnoea (OSA) and those where surgery is not an option. The premise for use of this group of medications is that inflammation in the upper airway of children with OSA differs from that of children without OSA and inflammation contributes to adenotonsillar hypertrophy.1

Previous studies investigating the role of anti-inflammatory treatment for childhood OSA is relatively scarce. This literature includes trials of nasal corticosteroids2 as well as the leukotriene receptor antagonist montelukast3 and combination therapy.4 The previous study of montelukast alone for 16 weeks was an open-label trial which demonstrated reduction in adenoid size as well as respiratory-related sleep disturbances in children with mild OSA, changes that were absent in those using placebo.3 The present study adds to the literature by using a more robust design and extending the treatment group to include children with both mild and moderate OSA. While changes in objective measures of severity in response to anti-inflammatory medications, including montelukast, may be somewhat modest, the direction of the effects is, at the very least, supportive of the need for additional studies in larger populations with longer follow-up and comparison to standard treatments.

One major limitation of this study is the use of a placebo group as the control as opposed to a surgical treatment comparison group. The difficulty with this approach is that non-severe OSA, as the authors’ state, is associated with significant morbidity. This makes the choice of a placebo comparison challenging as ‘no treatment’ would not be a suitable recommendation for children with non-severe OSA. As adenotonsillectomy is the most commonly recommended therapy for OSA in childhood, a more useful study would be a comparison of montelukast to standard surgical therapy.

The current study does not provide sufficient novel information to result in a change in clinical practice. It does, however, support the use of montelukast as safe and potentially efficacious in children with non-severe OSA, at least as short-term therapy. The results may not generalise to children with comorbid medical conditions where surgery is not an option but does suggest that anti-inflammatory medications, such as montelukast, deserve further investigation as possible options for OSA treatment in childhood.


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  • Funding None.

  • Competing interests None.