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Published on: April 8, 2013
Effectiveness of Intranasal Mometasone Furoate vs Saline for Sleep-Disordered Breathing in Children: A Randomized
Alice Baker1,2,3, Anneke Grobler1,2, Karen Davies4
1Department of Paediatrics, University of Melbourne, Melbourne, Australia.
Insights
Intranasal mometasone did not significantly improve obstructive sleep-disordered breathing (SDB) symptoms in children compared to saline. This suggests many children with SDB may be managed initially in primary care without specialist referral.
Area of Science:
- Pediatrics
- Sleep Medicine
- Otolaryngology
Background:
- Obstructive sleep-disordered breathing (SDB) affects over 12% of children, causing significant morbidity.
- Intranasal corticosteroids may improve SDB, but effects on symptoms and quality of life are unclear.
Purpose of the Study:
- To compare the efficacy of intranasal mometasone furoate versus saline in improving SDB symptoms and quality of life in children.
- To assess if mometasone furoate offers benefits beyond placebo for pediatric SDB.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled trial (MIST trial) involving children aged 3-12 years with SDB symptoms.
- Participants received daily intranasal mometasone furoate (50 μg) or saline (0.9%) for 6 weeks.
- Primary outcome was resolution of significant SDB symptoms, measured by parental report using the SDB Score.
Main Results:
- No significant difference in SDB symptom resolution was observed between the mometasone group (44%) and the saline group (41%) at 6 weeks (risk difference, 4%; 95% CI, -8% to 16%; P=.51).
- Adverse effects like epistaxis and nasal irritation were reported in both groups, with slightly higher incidence in the saline group for epistaxis and nasal itch/irritation.
Conclusions:
- Intranasal mometasone furoate demonstrated no significant advantage over saline for managing SDB symptoms in children.
- Findings suggest that a substantial proportion of children with SDB could potentially be managed in primary care, potentially avoiding specialist referral.
Importance:
Obstructive sleep-disordered breathing (SDB) in children is characterized by snoring and difficulty breathing during sleep. SDB affects at least 12% of otherwise healthy children and is associated with significant morbidity. Evidence from small clinical trials suggests that intranasal corticosteroids improve SDB as measured by polysomnography; however, the effect on symptoms and quality of life is unclear.
Objective:
To determine whether intranasal mometasone furoate is more effective than intranasal saline for improving symptoms and quality of life in children with SDB.
Design, Setting, And Participants:
The MIST trial was a multicenter, randomized, double-blind, placebo-controlled trial, recruiting participants from June 8, 2018, to February 13, 2020. Children aged 3 to 12 years who were referred to a specialist for significant SDB symptoms were included; exclusions were previous adenotonsillectomy, body mass index greater than the 97th percentile, and severe SDB. Randomization was stratified by site, and data were analyzed on an intention-to-treat basis from October 28, 2020, to September 25, 2022.
Interventions:
Participants were randomly assigned to receive mometasone furoate, 50 μg, or sodium chloride (saline), 0.9%, 1 spray per nostril daily, dispensed in identical bottles.
Main Outcomes And Measures:
The primary outcome was resolution of significant SDB symptoms (ie, reduction to a level no longer requiring referral to a specialist as per the American Academy of Pediatrics guidelines) at 6 weeks, measured by parental report of symptoms using the SDB Score.
Results:
A total of 276 participants (mean [SD] age, 6.1 [2.3] years; 146 male individuals [53%]) were recruited, 138 in each treatment arm. Resolution of significant SDB symptoms occurred in 56 of 127 participants (44%) in the mometasone group and 50 of 123 participants (41%) in the saline group (risk difference, 4%; 95% CI, -8% to 16%; P = .51) with 26 participants lost to follow-up and missing values managed by multiple imputation. The main adverse effects were epistaxis, affecting 12 of 124 participants (9.7%) in the mometasone group and 18 of 120 participants (15%) in the saline group, and nasal itch/irritation, affecting 12 of 124 participants (9.7%) in the mometasone group and 22 of 120 participants (18%) in the saline group.
Conclusions And Relevance:
Results of this randomized clinical trial suggest that there was no difference in treatment effect between intranasal mometasone and saline for the management of SDB symptoms. 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.
Trial Registration:
Australian New Zealand Clinical Trials Registry: ANZCTRN12618000448246.
