This trial is active, not recruiting.

Condition obstructive sleep apnea
Treatments budesonide nasal spray and a montelukast pill, placebo: sugar pill and salt water nasal spray
Phase phase 3
Sponsor Romaker & Associates
Collaborator Merck Sharp & Dohme Corp.
Start date September 2010
End date June 2013
Trial size 40 participants
Trial identifier NCT01089647, Adult OSA drug study, IISP 37206


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
treatment arm
budesonide nasal spray and a montelukast pill
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 and salt water nasal spray
sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks

Primary Outcomes

decrease the number of apnea/hypopnea to <5 per hour of sleep
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Montelukast and Nasa ICS for Treatment of Mild Obstructive Sleep Apnea in Adults
Principal investigator Ann Romaker, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2013.
Information provided to ClinicalTrials.gov by Romaker & Associates.