Trial Outcomes & Findings for Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen? (NCT NCT00716963)

NCT ID: NCT00716963

Last Updated: 2018-05-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 7 participants
• Primary outcome timeframe: Before inhalation 3 hours
• Results posted on: 2018-05-29

Participant Flow

Participant milestones

Measure	Fluticasone/Budesonide/Placebo Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.	Fluticasone/Placebo/Budesonide Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.	Budesonide/Fluticasone/Placebo Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge.	Budesonide/Placebo/Fluticasone Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.	Placebo/Fluticasone/Budesonide Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge.	Placebo/Budesonide/Fluticasone Subjects receive placebo after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Budesonide after early allergic response induced by allergen challenge. At least 2 week wash out period. Subjects receive Fluticasone after early allergic response induced by allergen challenge.
Overall Study STARTED	2	1	1	1	1	1
Overall Study COMPLETED	1	1	1	1	1	1
Overall Study NOT COMPLETED	1	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does Fluticasone Propionate Reduce the Late Allergic Reaction When the Drug is Given Post-allergen?

Baseline characteristics by cohort

Measure	Screening/Baseline Participants n=7 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Before inhalation 3 hours

Population: Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.

Outcome measures

Measure	Fluticasone Propionate (Flovent Diskus) 250 mcg n=6 Participants	Budesonide 400mcg n=6 Participants	Placebo n=6 Participants
The Magnitude of the Early Asthmatic Response, Expressed as a Percentage Change in FEV1.	-30.5 percentage fall FEV1 Standard Deviation 9.3	-39.0 percentage fall FEV1 Standard Deviation 12.3	-31.9 percentage fall FEV1 Standard Deviation 10.6

PRIMARY outcome

Timeframe: 7 hours after challenge

Population: Instead of re-listing participant flow, data was taken from each subject arm and re-listed here as the 3 arms each subject underwent.

Outcome measures

Measure	Fluticasone Propionate (Flovent Diskus) 250 mcg n=6 Participants	Budesonide 400mcg n=6 Participants	Placebo n=6 Participants
The Magnitude of the Late Asthmatic Response, Expressed as a Percentage Change in FEV1.	-11.6 percentage fall FEV1 Standard Deviation 14.2	-14.7 percentage fall FEV1 Standard Deviation 6.6	-24 percentage fall FEV1 Standard Deviation 7.2

SECONDARY outcome

Timeframe: Before inhalation both evaluations (0 hours)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: sputum @ 7 hours

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hours methacholine and sputum

Outcome measures

Outcome data not reported

Adverse Events

Fluticasone Propionate (Flovent Diskus) 250 mcg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Budesonide 400mcg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

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

Dr. Gail Gauvreau

McMaster University

Phone: 905-525-9140

Email: gauvreau@mcmaster.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60