Phase 3
Completed N=34
Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)
Source: ClinicalTrials.gov NCT01089647 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: 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
◆ Published Evidence
Emerging
19citations · ~3 / year
Effects of Medical Therapy on Mild Obstructive Sleep Apnea in Adult Patients.
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.
Linked Publications
-
Effects of Medical Therapy on Mild Obstructive Sleep Apnea in Adult Patients.
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 |
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) and the linked publication. 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. Informational only — not medical advice.