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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
budesonide and montelukast
Placebo
Sponsored by
Romaker & Associates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA, Medical treatment

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Romaker & Associates
  • Romaker & Assoc

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

budesonide and montelukast

placebo

Arm Description

treatment arm

sugar pill, salt water nasal spray

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 17, 2010
Last Updated
November 30, 2018
Sponsor
Romaker & Associates
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01089647
Brief Title
Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)
Official Title
Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Romaker & Associates
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
OSA, Medical treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
budesonide and montelukast
Arm Type
Active Comparator
Arm Description
treatment arm
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
sugar pill, salt water nasal spray
Intervention Type
Drug
Intervention Name(s)
budesonide and montelukast
Intervention Description
budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
Primary Outcome Measure Information:
Title
Number of Participants With a Decrease in the Number of Apnea and/or Hypopnea Events to <5 Per Hour of Sleep
Description
by decreasing nasal congestion, we hope to decrease the number of respiratory events per hour of sleep back to the normal range
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Romaker, MD
Organizational Affiliation
Romaker & Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Romaker & Associates
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Romaker & Assoc
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31383235
Citation
Smith DF, Sarber KM, Spiceland CP, Ishman SL, Augelli DM, Romaker AM. Effects of Medical Therapy on Mild Obstructive Sleep Apnea in Adult Patients. J Clin Sleep Med. 2019 Jul 15;15(7):979-983. doi: 10.5664/jcsm.7876.
Results Reference
derived

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

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