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

The University of Chicago

Status and phase

Completed

Phase 4

Conditions

Childhood Obstructive Sleep Apnea Syndrome (OSAS)

Treatments

Drug: fluticasone furoate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00603044

15868B

Details and patient eligibility

About

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.

Full description

The objective was to determine the effect of intranasal corticosteroid therapy on T-regulatory cells and other inflammatory cytokines in adenoid tissues in children with obstructive sleep apnea syndrome.Children were randomized to either no treatment or treatment with fluticasone furoate nasal spray, 55 μg/nostril daily, for 2 weeks before adenotonsillectomy. Adenoid tissue was obtained at the time of the procedure.

Enrollment

24 patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

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.