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

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Collaborator: GlaxoSmithKline
• Treatments: Fluticasone; Xhance

Criteria

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.