At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 211 enrolled
Drug / intervention
Nasal Fluticasone +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Utility of Nasal Steroids for Treatment of Childhood Obstructive Sleep Apnea
In Brief
A Phase 3 clinical trial evaluating Nasal Fluticasone and Placebo for Obstructive Sleep Apnea Syndrome. Completed, enrolled 211 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea Syndrome
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 2014
Enrollment StartSep 2014
Primary CompletionDec 2019
Study CompletionOct 2021
TodayJul 2026
First PostedJul 3, 2014
Enrollment StartSep 1, 2014
Primary CompletionDec 30, 2019
Study CompletionOct 30, 2021
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 12.0 years ago
Interventions
Nasal Fluticasonedrug
One spray per nostril, per day.
Placebodrug
One spray per nostril, per day.