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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Childhood Obstructive Sleep Apnea Syndrome (OSAS)

Intervention / Treatment
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* Drug: fluticasone furoate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fluticasone furoate<br>55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy | Drug: fluticasone furoate<br>* treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy<br>* Other names: Veramyst;|
| No Intervention: No treatment<br> | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted Volume of the Removed Adenoids | 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. | following adenoidectomy (2 weeks) |