Title
Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)
Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults
Phase
Phase 3Lead Sponsor
Romaker & AssociatesStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Obstructive Sleep ApneaIntervention/Treatment
montelukast budesonide ...Study Participants
34In 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.
40 adults with mild OSA (< 5 apneas/hypopneas per hour of sleep) will receive either a combination of two medicines that decrease nasal congestion-montelukast and nasal budesonide-or a placebo pill and nasal spray. After 3 months of therapy, a repeat sleep study will be done to determine the differences, if any, in the frequency of sleep disordered breathing in the two groups.
budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks
sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
Inclusion Criteria: age 18 - 100 years RDI between 5 - 15 all races both sexes Exclusion Criteria: craniofacial, syndromic, neurological abnormalities current or previous use of Singular, Rhinocort within last 6 months acute upper respiratory infections recent nasal trauma, nasal surgery, nasal septum perforation known immunodeficiency or under going immunosuppressant therapy current therapy with drugs that interact with Montelukast or Budesonide
| Event Type | Organ System | Event Term | Budesonide and Montelukast | Placebo |
|---|
by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range
