Childhood Obstructive Sleep Apnea Syndrome (OSAS) Clinical Trial
Official title:
Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome
| Verified date | April 2015 |
| Source | University of Chicago |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 24 |
| Est. completion date | August 2009 |
| Est. primary completion date | January 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 12 Years |
| 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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United States | University of Chicago | Chicago | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| University of Chicago | GlaxoSmithKline |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | No |
| Primary | 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) | No |
| Primary | 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) | No |
| Primary | 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) | No |
| Primary | Amount of TGF Secreted by Adenoid Cells After PHA Stimulation | Amount of TGF secreted by adenoid cells after PHA stimulation | following adenoidectomy (2 weeks) | No |
| Secondary | 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) | No |