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

Phase 3

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: Placebo; Drug: budesonide and montelukast

• Registration Number: NCT01089647
• Lead Sponsor: Romaker & Associates

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2010-03-17
• Study First Submitted QC: 2010-03-17
• Study First Posted: 2010-03-18
• Study Start: 2010-09
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2018-09-11
• Status Verified: 2018-11
• Results First Submitted QC: 2018-11-30
• Last Update Submitted: 2018-11-30
• Results First Posted: 2018-12-03
• Last Update Posted: 2018-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	sugar pill, salt water nasal spray
budesonide and montelukast	budesonide and montelukast	treatment arm

Primary Outcome Measures

Name	Time	Method
Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep	3 months	by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range

Trial Locations

Locations (2)

Romaker & Associates; 🇺🇸 Kansas City, Missouri, United States

Romaker & Assoc; 🇺🇸 Kansas City, Missouri, United States