Phase 4
N=24
Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome
Childhood Obstructive Sleep Apnea Syndrome (OSAS)
Bottom Line
View on ClinicalTrials.gov: NCT00603044 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
May 2015
Primary outcome: Primary: Number of CD25 Pos/FoxP3 Positive Cells — 12.7; 14.6 cells per High power field (HPF)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- fluticasone furoate (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Jan 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of CD25 Pos/FoxP3 Positive Cells |
12.7; 14.6 | — |
| PRIMARY Number of CD4 Pos/FOXP3 Positive Cells |
22.5; 21.4 | — |
| PRIMARY IL-10 Staining Intensity |
437.4; 479.8 | — |
| PRIMARY Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation |
115; 210 | — |
| PRIMARY Amount of TGF Secreted by Adenoid Cells After PHA Stimulation |
944; 906 | — |
| SECONDARY Adjusted Volume of the Removed Adenoids |
13.0; 16.8 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00603044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.