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



Status:Completed
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 100
Updated:12/5/2018
Start Date:September 2010
End Date:June 2014

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Trial Summary
Trial Overview
Inclusion Criteria

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.

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.

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
We found this trial at
2
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Romaker & Associates
Kansas City, Missouri 64111
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mi
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Kansas City, MO
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Romaker & Assoc
Kansas City, Missouri 64111
?
mi
from
Kansas City, MO
Click here to add this to my saved trials