Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome



Status:Completed
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:2 - 12
Updated:11/8/2014
Start Date:January 2008
End Date:June 2009
Contact:Fuad M Baroody, MD
Email:fbaroody@surgery.bsd.uchicago.edu
Phone:773-702-5889

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Trial Summary
Trial Overview
Inclusion Criteria
The purpose of this research is to find out how a nasal spray (fluticasone furoate),
sometimes given to children with obstructive sleep apnea syndrome (OSAS), works on certain
cells within a child's adenoids. We hypothesize that intranasal steroids lead to an
upregulation of T regulatory cells in the adenoid tissues of children with OSAS. This will
result in a local reduction in inflammation and edema explaining the improvement in OSAS.


Inclusion Criteria:

- Age: between 2 and 12 years

- Polysomnogram results showing AHI >5/hr irrespective of saturations

- No other significant medical problems except well controlled asthma

- No chronic medication intake except bronchodilators and leukotriene receptor
antagonists

- No systemic steroids within the past month

- No intranasal steroids within the past 2 weeks

Exclusion Criteria:

- Patients with OSAS who are overweight (BMI>95th percentile for age) or who have
neurological or craniofacial abnormalities as these tend to have OSAS related to
these factors per se.

- Females of the specified age group who have already had their first period.
We found this trial at
1
site
University of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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