Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Romaker & Associates
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Budesonide; Montelukast

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