At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 34 enrolled
Drug / intervention
budesonide and montelukast +1 moredrug
Likely dose
budesonide and montelukast 10 mgfrom 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.
Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults
In Brief
A Phase 3 clinical trial evaluating budesonide and montelukast and Placebo for Obstructive Sleep Apnea. Completed, enrolled 34 participants across 2 sites.
Detailed Summary
In children with mild apnea combined therapy with an inhaled nasal steroid and a medication that decreased nasal congestion (montelukast) was shown to be effective. We are testing to see if this combination works in adults with mild apnea as well.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2010
Enrollment StartSep 2010
Primary CompletionJun 2014
TodayJul 2026
First PostedMar 18, 2010
Enrollment StartSep 1, 2010
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.3 years ago
Interventions
budesonide and montelukastdrug
budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks
Placebodrug
sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks