Trial Outcomes & Findings for The Effect of Inhibition of B7-mediated Costimulation on Allergic Airway Inflammation in Mild Atopic Asthmatics (NCT NCT00784459)

NCT ID: NCT00784459

Last Updated: 2014-02-05

Results Overview

collected prior to randomization to abatacept or placebo

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 24 participants
• Primary outcome timeframe: baseline
• Results posted on: 2014-02-05

Participant Flow

recruited from asthma patient subject registry

Participant milestones

Measure	Placebo Placebo : Treatment with Placebo, IV	Treatment With Abatacept abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
Overall Study STARTED	11	13
Overall Study COMPLETED	11	11
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Placebo Placebo : Treatment with Placebo, IV	Treatment With Abatacept abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
Overall Study Adverse Event	0	2

Baseline Characteristics

The Effect of Inhibition of B7-mediated Costimulation on Allergic Airway Inflammation in Mild Atopic Asthmatics

Baseline characteristics by cohort

Measure	Placebo n=11 Participants Placebo : Treatment with Placebo, IV	Treatment With Abatacept n=13 Participants abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28 years STANDARD_DEVIATION 7.8 • n=5 Participants	35 years STANDARD_DEVIATION 9.8 • n=7 Participants	31 years STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	13 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline

collected prior to randomization to abatacept or placebo

Outcome measures

Measure	Placebo n=11 Participants Placebo : Treatment with Placebo, IV	Treatment With Abatacept n=13 Participants abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
Baseline Percentage of Eosinophils Recovered in the BAL Prior to Segmental Allergen Challenge	42 percentage of cells Standard Deviation 30	19 percentage of cells Standard Deviation 15

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Measure	Placebo n=11 Participants Placebo : Treatment with Placebo, IV	Treatment With Abatacept n=11 Participants abatacept : Treatment with abatacept, 10 mg/kg IV, for 5 doses.
Percentage of Eosinophils Recovered Following Segmental Allergen Challenge Following 3 Months of Placebo or Abatacept	44 percentage of cells Standard Deviation 28	17 percentage of cells Standard Deviation 17

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment With Abatacept

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 Jonathan Green

Washington University

Phone: 314-747-3591

Email: jgreen@wustl.edu

Results disclosure agreements

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

Restriction type: GT60