Trial Outcomes & Findings for The Effect of Allergen Inhalation on Sputum Myeloid and Plasmacytoid Dendritic Cells in Mild Atopic Asthmatics (NCT NCT00625989)

Results Overview

Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

12 participants

Primary outcome timeframe

24 hrs

Results posted on

2018-05-21

Participant Flow

Participant milestones

Participant milestones
Measure	Diluent Then Allergen Challenge Subjects were screened, then given a 2 week washout period. Samples collected on day 1 according to protocol. Day 2 diluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol. Two week wash out period. Samples collected on day 1, after washout, according to protocol. Day 2, after washout, allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol.	Allergen Then Diluent Challenge Subjects were screened, then given a 2 week washout period. Samples collected on day 1 according to protocol. Day 2 allergen challenge was preformed and samples collected according to the protocol. Subjects returned on day 3 for 24 hour follow up and samples collected according to the protocol. Two week wash out period. Samples collected on day 1, after washout, according to protocol. Day 2, after washout, dilluent challenge was preformed and samples collected according to the protocol. Subjects returned on day 3, after wash out, for 24 hour follow up and samples collected according to the protocol.
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Allergen Inhalation on Sputum Myeloid and Plasmacytoid Dendritic Cells in Mild Atopic Asthmatics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mild Asthmatics n=12 Participants Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Age, Continuous	28.6 years STANDARD_DEVIATION 3.2 • n=93 Participants
Sex: Female, Male Female	7 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants

PRIMARY outcome

Timeframe: 24 hrs

Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.

Outcome measures

Outcome measures
Measure	Diluent n=12 Participants Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.	Allergen n=12 Participants Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
The Primary Outcome Measure for This Study is the Number of Sputum Myeloid Dendritic Cells	32800 number of cells/g of sputum Standard Deviation 13100	89100 number of cells/g of sputum Standard Deviation 27000

PRIMARY outcome

Timeframe: 24 hrs

Flow-cytometric acquisitions were used to determine the percentage of each type of mononuclear cell. These percentages were multiplied by the number of sputum mononuclear cells calculated by using total and differential cell counts of the sputum sample.

Outcome measures

Outcome measures
Measure	Diluent n=12 Participants Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.	Allergen n=12 Participants Mild asthmatics who require only short-acting beta agonist bronchodilator treatment as required.
The Primary Outcome Measure for This Study is the Number of Sputum Plasmacytoid Dendritic Cells	16000 number of cells/g of sputum Standard Deviation 8700	39900 number of cells/g of sputum Standard Deviation 12200

SECONDARY outcome

Timeframe: Before inhalation (0hrs)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 hrs

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 hrs

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 72 hrs

Outcome measures

Outcome data not reported

Adverse Events

Mild Asthmatics

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: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place