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

Completed · Phase 4

Conditions studied: Childhood Obstructive Sleep Apnea Syndrome (OSAS)

In brief

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.

Key facts

Study ID

NCT00603044

Run by

University of Chicago

People needed

24

Starts

2008-01-01

Expected to finish

2009-08-01

Last updated by the study team

2015-05-04

Who can join

Age: 2 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.