Trial Outcomes & Findings for Mechanism of Action of Fluticasone Furoate in Childhood Obstructive Sleep Apnea Syndrome (NCT NCT00603044)

NCT ID: NCT00603044

Last Updated: 2015-05-04

Results Overview

The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

24 participants

Primary outcome timeframe

following adenoidectomy (2 weeks)

Results posted on

2015-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	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	No Treatment Subjects in this arm received no treatment.
Overall Study STARTED	11	13
Overall Study COMPLETED	11	13
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fluticasone Furoate n=11 Participants 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	No Treatment n=13 Participants Subjects in this arm received no treatment.	Total n=24 Participants Total of all reporting groups
Age, Continuous	5.24 years STANDARD_DEVIATION 3.12 • n=93 Participants	5.93 years STANDARD_DEVIATION 3.32 • n=4 Participants	5.62 years STANDARD_DEVIATION 1.76 • n=27 Participants
Sex: Female, Male Female	5 Participants n=93 Participants	8 Participants n=4 Participants	13 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants

PRIMARY outcome

Timeframe: following adenoidectomy (2 weeks)

Population: Some subjects were excluded due to technical issues.

The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25

Outcome measures

Outcome measures
Measure	Fluticasone Furoate n=11 Participants 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	No Treatment n=10 Participants Subjects in this arm received no treatment.
Number of CD25 Pos/FoxP3 Positive Cells	12.7 cells per High power field (HPF) Interval 3.1 to 35.2	14.6 cells per High power field (HPF) Interval 3.1 to 36.7

PRIMARY outcome

Timeframe: following adenoidectomy (2 weeks)

Population: Some subjects were excluded due to technical issues.

The number of tissue T-regulatory cells, as determined by staining with FOXP3, CD4, and CD25

Outcome measures

Outcome measures
Measure	Fluticasone Furoate n=11 Participants 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	No Treatment n=10 Participants Subjects in this arm received no treatment.
Number of CD4 Pos/FOXP3 Positive Cells	22.5 cells per High power field (HPF) Interval 3.3 to 38.8	21.4 cells per High power field (HPF) Interval 3.7 to 29.4

PRIMARY outcome

Timeframe: following adenoidectomy (2 weeks)

Population: Some subjects were excluded due to technical issues.

IL-10 staining intensity on immunohistochemical staining of adenoid tissues. Units are Integrated optical density (IOD)/100 micrometer squared.

Outcome measures

Outcome measures
Measure	Fluticasone Furoate n=9 Participants 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	No Treatment n=10 Participants Subjects in this arm received no treatment.
IL-10 Staining Intensity	437.4 IOD/100 micrometer squared Standard Error 85.6	479.8 IOD/100 micrometer squared Standard Error 6.0

PRIMARY outcome

Timeframe: following adenoidectomy (2 weeks)

Population: Some subjects were excluded due to technical issues.

Amount of IL-10 secreted by adenoid cells after PHA stimulation

Outcome measures

Outcome measures
Measure	Fluticasone Furoate n=11 Participants 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	No Treatment n=12 Participants Subjects in this arm received no treatment.
Amount of IL-10 Secreted by Adenoid Cells After PHA Stimulation	115 picogram per milliliter (pg/mL) Interval 6.0 to 204.0	210 picogram per milliliter (pg/mL) Interval 15.0 to 510.0

PRIMARY outcome

Timeframe: following adenoidectomy (2 weeks)

Population: Some subjects were excluded due to technical issues.

Amount of TGF secreted by adenoid cells after PHA stimulation

Outcome measures

Outcome measures
Measure	Fluticasone Furoate n=11 Participants 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	No Treatment n=11 Participants Subjects in this arm received no treatment.
Amount of TGF Secreted by Adenoid Cells After PHA Stimulation	944 picogram per milliliter (pg/mL) Interval 519.0 to 2555.0	906 picogram per milliliter (pg/mL) Interval 598.0 to 1071.0

SECONDARY outcome

Timeframe: following adenoidectomy (2 weeks)

Population: Some subjects were excluded due to technical issues.

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.

Outcome measures

Outcome measures
Measure	Fluticasone Furoate n=10 Participants 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	No Treatment n=9 Participants Subjects in this arm received no treatment.
Adjusted Volume of the Removed Adenoids	13.0 mL/kg x100 Standard Error 2.7	16.8 mL/kg x100 Standard Error 3.8

Adverse Events

Fluticasone Furoate

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Fuad Baroody, MD

The University of Chicago Medicine

Phone: (773) 702-4790

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place