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

Phase 4

Completed

Brief 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.

Detailed 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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Fluticasone furoate	fluticasone furoate	55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy

Primary Outcome Measures

Name	Time	Method
Number of CD25 Pos/FoxP3 Positive Cells	following adenoidectomy (2 weeks)	The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25
Number of CD4 Pos/FOXP3 Positive Cells	following adenoidectomy (2 weeks)	The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25
IL-10 Staining Intensity	following adenoidectomy (2 weeks)	IL-10 staining intensity on immunohistochemical staining of adenoid tissues. Units are Integrated optical density (IOD)/100 micrometer squared.
Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation	following adenoidectomy (2 weeks)	Amount of IL-10 secreted by adenoid cells after PHA stimulation
Amount of TGF Secreted by Adenoid Cells After PHA Stimulation	following adenoidectomy (2 weeks)	Amount of TGF secreted by adenoid cells after PHA stimulation

Secondary Outcome Measures

Name	Time	Method
Adjusted Volume of the Removed Adenoids	following adenoidectomy (2 weeks)	To adjust for different weights of the children, the volume of the adenoids, estimated by water displacement in the operating room in mL, was divided by the respective weights (kg) of the patients and multiplied by 100.