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

Condition(s) targeted: Childhood Obstructive Sleep Apnea Syndrome (OSAS)

Intervention: fluticasone furoate (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Chicago

Official(s) and/or principal investigator(s):
Fuad M Baroody, MD, Principal Investigator, Affiliation: University of Chicago

Overall contact:
Fuad M Baroody, MD, Phone: 773-702-5889, Email: fbaroody@surgery.bsd.uchicago.edu

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.

Official title: Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome

Study design: Treatment, Randomized, Open Label, Parallel Assignment

Primary outcome:

the number of cells positive for IL-10 and FOXP3 on immunohistochemical staining of adenoid tissues

the amount of IL-10 and TGF-alpha secreted by adenoid cells after stimulation

Secondary outcome: weight of the removed adenoids to be compared between the 2 groups.

Minimum age: 2 Years. Maximum age: 12 Years. Gender(s): Both.

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.

Fuad M Baroody, MD, Phone: 773-702-5889, Email: fbaroody@surgery.bsd.uchicago.edu

University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Fuad M Baroody, MD, Principal Investigator

Starting date: January 2008
Ending date: June 2009
Last updated: July 16, 2008