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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00603044

Enrollment

Registered

2008-01-28

Start date

2008-01-31

Completion date

2009-08-31

Last updated

2015-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obstructive Sleep Apnea Syndrome (OSAS)

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.

Interventions

DRUGfluticasone furoate

treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

2 Years to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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	11
No Treatment Subjects in this arm received no treatment.	13
Total	24

Baseline characteristics

Characteristic	Fluticasone Furoate	No Treatment	Total
Age, Continuous	5.24 years STANDARD_DEVIATION 3.12	5.93 years STANDARD_DEVIATION 3.32	5.62 years STANDARD_DEVIATION 1.76
Sex: Female, Male Female	5 Participants	8 Participants	13 Participants
Sex: Female, Male Male	6 Participants	5 Participants	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 11	0 / 13
serious Total, serious adverse events	0 / 11	0 / 13