A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel, Dose-Finding Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Adalimumab in Subjects With Refractory Asthma
Sponsor study identifier
interventional
272
0 countries
N/A
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
Not reported
Date not reportedTo evaluate the efficacy of SC injections of 3 regimens of adalimumab vs. placebo in the change in post-bronchodilator FEV1 from Baseline to Week 16 when used in the treatment of refractory asthma.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
August 6, 2007
Actual (reported)August 8, 2007
Actual (reported)The primary efficacy endpoint is the change from Baseline in post-bronchodilator FEV1 in subjects treated with adalimumab vs. placebo.
Week 16
Proportion of subjects with at least one asthma exacerbation from Baseline to the end of the double-blind period
Week 16
Changes from Baseline in post-bronchodilator FEV1
Time points other thanWeek 16
Change from Baseline in pre-bronchodilator FEV1
Change from Baseline (pre-bronchodilator) in FEV1
30 minutes postbronchodilator
Change from Baseline in percent predicted FEV1
Beverly Paperiello
Abbott
First Submitted
August 6, 2007
First Posted
August 8, 2007
Study Start
August 2007
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
November 6, 2007
Record last verified: 2007-11
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Source retrieved:
A Clinical Trial Evaluating the Safety and Effectiveness of Golimumab in Patients With Severe, Persistent Asthma
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