NCT02180672

Steroids for Pediatric Apnea Research in Kids

Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 211 (actual)
• Sponsor: Children's Hospital of Philadelphia · Academic / Other
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

This double-blind, randomized controlled trial will evaluate the use of nasal corticosteroids for the treatment of the childhood obstructive sleep apnea syndrome (OSAS). Efficacy, duration of action and side-effects will be determined.

Detailed description

Several studies have suggested that Nasal corticosteroids (NCS) or leukotriene antagonists may be effective in the treatment of childhood OSAS. However, these studies have been limited by factors such as small size, lack of randomization and blinding, short-term follow-up, involvement of children with only very mild OSAS, and/or lack of stratifying for the presence of atopy. Therefore, investigators will plan a randomized controlled trial evaluating the efficacy and safety of NCS vs placebo in children with mild to moderate OSAS. The overall hypothesis is that NCS will be safe and efficacious in the treatment of mild to moderate childhood OSAS, particularly in children with asthma/atopy, but will require ongoing maintenance therapy.

Conditions

• Obstructive Sleep Apnea Syndrome

Interventions

Type	Name	Description
DRUG	Nasal Fluticasone	One spray per nostril, per day.
DRUG	Placebo	One spray per nostril, per day.

Timeline

• Start date: 2014-09-01
• Primary completion: 2019-12-30
• Completion: 2021-10-30
• First posted: 2014-07-03
• Last updated: 2021-11-10
• Results posted: 2021-03-10

Locations

1 site across 1 country: United States