Investigators from the University of Pennsylvania School of Medicine, Philadelphia, PA, and Johns Hopkins University, Baltimore, MD, conducted a randomized controlled trial to assess the effectiveness of intranasal corticosteroids (INCS) in reducing sleep apnea and associated symptoms in children with obstructive sleep apnea syndrome (OSAS). Children 5-12 years old with OSAS, a baseline obstructive apnea hypopnea index (OAHI) between 2 and 30 events per hour, and no significant hypoxia during sleep, were eligible for the study. At enrollment, participants were randomized in a 2:1 manner to INCS (fluticasone propionate 110 mg daily) or placebo for 3 months. Randomization was stratified by history of atopy or asthma, use of inhaled corticosteroids for asthma, obesity, and seasonality. After 3 months, children in the INCS group were re-randomized to INCS or placebo for 9 additional months; patients with OAHI >30 events/hour after 3 months were considered treatment failures and excluded from further participation. Study participants underwent polysomnography (PSG) evaluation at baseline, 3 months, and 12 months. In addition, multiple neurobehavioral, symptom, and quality of life (QOL) questionnaires were completed at these time points. The primary study outcome was change in OAHI from baseline to 3 months, and the main secondary outcome was change in OAHI from baseline to 12 months. Other secondary outcomes included change from baseline in questionnaire scores. Regression analysis was used to compare outcomes among children in the INCS groups or placebo groups, with adjustment for baseline OAHI and stratification variables.
A total of 134 children were enrolled, including 91 randomized to INCS and 43 to placebo. The overall median baseline OAHI was 5.8 (interquartile range 3.6 to 9.7) events/hour, and mean age was 8.2 ±2.2 years for those receiving INCS and 8.1 ±2.0 for placebo recipients. After 3 months of treatment, the median reduction in OAHI was -1.7 events/hour for those in the INCS group and -1.3 events/hour for those randomized to placebo (P = 0.77). There also were no significant differences between treatment groups in change from baseline in scores on the various neurobehavioral, symptom, and QOL questionnaires. After 3 months, 4 children receiving INCS and 6 in the placebo group had OAHI >30 and were excluded from further study participation, and 1 participant was withdrawn because of development of coloboma. The remaining participants were randomized to continue INCS for 9 more months or switched to placebo. At 12 months, there were no differences between children in the 2 treatment groups in change in OAHI from baseline.
The authors conclude that among children with OSAS, treatment with INCS was not significantly better than placebo in reducing obstructive apnea events.
Dr Dubik has disclosed no financial relationship relevant to this commentary. This commentary does not contain a discussion of an unapproved/investigative use of a commercial product/device.