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

November 30, 2018 updated by: Ann M. Romaker, MD, Romaker & Associates

Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Romaker & Associates
      • Kansas City, Missouri, United States, 64111
        • Romaker & Assoc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: budesonide and montelukast
treatment arm
Drug: budesonide and montelukast
budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks
Placebo Comparator: placebo
sugar pill, salt water nasal spray
Drug: Placebo
sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Romaker & Associates

Collaborators

Merck Sharp & Dohme LLC

Investigators

  • Principal Investigator: Ann Romaker, MD, Romaker & Associates

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

March 17, 2010

First Posted (Estimate)

March 18, 2010

Study Record Updates

Last Update Posted (Actual)

December 3, 2018

Last Update Submitted That Met QC Criteria

November 30, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Adult OSA drug study
  • IISP 37206 (Other Grant/Funding Number: Merck)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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