Montelukast and Inhaled Nasal Steroid Tx in Adult Obstructive Sleep Apnea (OSA)
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|
|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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, caregiver, investigator)|
decrease the number of apnea/hypopnea to <5 per hour of sleep
time frame: 3 months
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
|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.|
Call for more information