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| ID | Type | Description | Link |
|---|---|---|---|
| 15868B |
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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluticasone furoate | Active Comparator | 55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy |
|
| No treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluticasone furoate | Drug | treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fuad M Baroody, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluticasone Furoate | 55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy |
| FG001 | No Treatment | Subjects in this arm received no treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluticasone Furoate | 55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy |
| BG001 | No Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of CD25 Pos/FoxP3 Positive Cells | The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25 | Some subjects were excluded due to technical issues. | Posted | Median | Full Range | cells per High power field (HPF) | following adenoidectomy (2 weeks) |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fluticasone Furoate | 55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fuad Baroody, MD | The University of Chicago Medicine | (773) 702-4790 | fbaroody@surgery.bsd.uchicago.edu |
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| ID | Term |
|---|---|
| C523187 | fluticasone furoate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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Subjects in this arm received no treatment.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Primary | Number of CD4 Pos/FOXP3 Positive Cells | The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25 | Some subjects were excluded due to technical issues. | Posted | Median | Full Range | cells per High power field (HPF) | following adenoidectomy (2 weeks) |
|
|
|
| Primary | IL-10 Staining Intensity | IL-10 staining intensity on immunohistochemical staining of adenoid tissues. Units are Integrated optical density (IOD)/100 micrometer squared. | Some subjects were excluded due to technical issues. | Posted | Mean | Standard Error | IOD/100 micrometer squared | following adenoidectomy (2 weeks) |
|
|
|
| Primary | Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation | Amount of IL-10 secreted by adenoid cells after PHA stimulation | Some subjects were excluded due to technical issues. | Posted | Median | Full Range | picogram per milliliter (pg/mL) | following adenoidectomy (2 weeks) |
|
|
|
| Primary | Amount of TGF Secreted by Adenoid Cells After PHA Stimulation | Amount of TGF secreted by adenoid cells after PHA stimulation | Some subjects were excluded due to technical issues. | Posted | Median | Full Range | picogram per milliliter (pg/mL) | following adenoidectomy (2 weeks) |
|
|
|
| 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. | Some subjects were excluded due to technical issues. | Posted | Mean | Standard Error | mL/kg x100 | following adenoidectomy (2 weeks) |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | No Treatment | Subjects in this arm received no treatment. | 0 | 13 | 0 | 13 |
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| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |