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The study evaluated how intranasal mometasone furoate affected sleep-disordered breathing symptoms and patient quality of life by comparing its efficacy to intranasal saline in the pediatric patients.
Investigators questioned if 6 weeks of intranasal mometasone furate would be more effective than intranasal saline for the treatment of obstructive sleep-disordered breathing (SDB) in pediatric patients. Results from the double-blind, randomized clinical trial were recently published and showed about half of cases can be resolved with either treatment.
According to Alice Baker, MBBS, Department of Paediatrics, University of Melbourne, and a team of investigators, these data not only suggest intervention options for first-line treatment of sleep-disordered breathing in children, but that a large portion of patients can be managed in primary care.
The investigation was motivated by previous evidence indicating that intranasal corticosteroids improved SDB when measured by polysomnography in some small clinical trials. However, this team aimed to further evaluate this treatment's effect on symptoms and patient quality of life by comparing its efficacy to intranasal saline in the pediatric population.
Between June 2018-February 2020, a total of 276 patients between the ages of 3-12 years were recruited for the multicenter, double-blind, placebo controlled, clinical trial and randomized into 2 treatment arms of 138 children. Randomization was stratified by the site of the treatment center.
Gender of the study population was about equal with 53% being male. Investigators performed data analyses on an intention-to-treat basis from October 2020-September 2022.
Children were recruited for the trial based on referrals from a specialist due to significant sleep-disordered breathing symptoms. However, previous adenotonsillectomy, body mass index greater than the 97th percentile, and severe SDB were reasons for exclusion.
Once randomized, the pedatric patients began treatment of either mometasone furoate, 50 μg, or sodium chloride (saline), 0.9%, 1 spray per nostril daily, dispensed in identical bottles.
Significant sleep-disordered breathing symptoms resolved at similar rates with each intervention. In the mometasone group, 56 of 127 children (44%) were able to achieve meaningful results, as did 50 of 123 children (41%) in the saline group. The 26 patients not included were lost to follow-up and missing values.
As for adverse events, epistaxis was the primary occurrence, with 9.7% in the mometasone group, and 15% in the saline group, experiencing nose bleeds. 9.7% of children in the mometasone group, and 18% in the saline group reported irritation or itching in the nasal pathway.
According to investigators, the data from this trial suggest that there was no difference in treatment effect between intranasal mometasone and saline for when managing symptoms in children with sleep-disordered breathing.
"The results suggest that almost one-half of children with SDB could be initially managed in the primary care setting and may not require referral to specialist services, as is currently recommended," the team wrote.
The study "Effectiveness of Intranasal Mometasone Furoate vs Saline for Sleep-Disordered Breathing in Children" was published in JAMA Pediatrics.