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Intranasal Budesonide and Quality of Life in Pediatric Sleep-Disordered Breathing: A Randomized Controlled Trial
Gunnhildur Gudnadottir1, Eva Ellegård2, Johan Hellgren1
11 Department of Otorhinolaryngology, Sahlgrenska Academy at the University of Gothenburg, Gothenburg, Sweden.
Insights
Budesonide nasal spray significantly improved quality of life and reduced symptoms in children with sleep-disordered breathing. This treatment offers a safe and effective option for managing pediatric sleep issues.
Area of Science:
- Pediatric Otolaryngology
- Sleep Medicine
- Pharmacology
Background:
- Sleep-disordered breathing (SDB) negatively impacts children's quality of life.
- Snoring and apneas are common symptoms of SDB in pediatric populations.
- Current treatments for SDB in children often focus on surgical interventions.
Purpose of the Study:
- To evaluate the efficacy of budesonide nasal spray in improving health-related quality of life (HRQoL) and symptoms in children with SDB.
- To compare budesonide nasal spray with a placebo in a randomized, double-blind, controlled trial setting.
- To assess the impact of budesonide on specific SDB symptoms and objective measures like adenoid and tonsil size.
Main Methods:
- A randomized, parallel, double-blind, placebo-controlled trial was conducted with 60 children (ages 4-10) diagnosed with SDB.
- Participants received either budesonide nasal spray (64 μg/mL) or placebo twice daily for 6 weeks.
- Primary outcome was the change in the OSA-18 total score; secondary outcomes included individual OSA-18 domains, quality of life visual analog scale, symptom severity, and adenoid/tonsil size.
Main Results:
- Budesonide treatment resulted in a significantly greater improvement in the mean OSA-18 total score compared to placebo (19.5 vs 7.5, P = .0014).
- Significant improvements were observed in the sleep disturbance and caregivers' concerns domains of the OSA-18.
- Budesonide also led to improvements in quality of life, snoring, apneas, and nasal obstruction, with no serious treatment-related adverse events.
Conclusions:
- Intranasal budesonide is an effective treatment for improving quality of life and reducing symptoms in children with sleep-disordered breathing.
- The 6-week budesonide regimen demonstrated significant benefits over placebo, highlighting its therapeutic potential.
- Budesonide nasal spray represents a viable non-surgical option for managing pediatric SDB and its associated symptoms.
Abstract:
Objective To study the efficacy of budesonide nasal spray on the health-related quality of life and symptoms among children with sleep-disordered breathing. Study Design Randomized, parallel, double-blind, placebo-controlled trial. Setting Tertiary referral center. Subjects and Methods Sixty children (ages, 4-10 years) who were referred because of snoring and/or apneas for >3 months were included between January 2015 and June 2016 and randomized in a double-blind design to treatment with 64 μg/mL of budesonide nasal spray (n = 30) or placebo nasal spray (n = 30) twice daily for 6 weeks. The primary outcome measurement was the change in the mean OSA-18 total score from baseline. Other variables examined were individual OSA-18 domains, a visual analog scale for quality of life, symptoms (snoring, apneas, and nasal obstruction), and adenoid and tonsil size. The trial was investigator initiated and not sponsored by the pharmaceutical industry. Results Fifty-five children completed the trial. An intention-to-treat analysis revealed a significantly greater improvement in the mean OSA-18 total score after treatment with budesonide than placebo (19.5 vs 7.5, P = .0014). Intranasal budesonide also improved 2 OSA-18 domains (sleep disturbance, caregivers' concerns), the visual analog scale score for quality of life, as well as snoring, apneas, and nasal obstruction. No serious adverse events were reported that could be linked to the treatment. Conclusion Among children with sleep-disordered breathing, 6 weeks' treatment with intranasal budesonide significantly improved quality of life and symptoms as compared with placebo nasal spray.
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