Phase 3
N=34
Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT01089647 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep — 5; 3 Participants — p==0.946
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- budesonide and montelukast (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Romaker & Associates
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep |
5; 3 | =0.946 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01089647). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.