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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2014-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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budesonide and montelukast

treatment arm

Group Type ACTIVE_COMPARATOR

budesonide and montelukast

Intervention Type DRUG

budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks

placebo

sugar pill, salt water nasal spray

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks

Interventions

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budesonide and montelukast

budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks

Intervention Type DRUG

Placebo

sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No