A Study to Evaluate the Safety and Efficacy of HAE1 in Subjects With Moderate to Severe Allergic Asthma
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|ClinicalTrials.gov Identifier: NCT00406965|
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : January 2, 2008
|Condition or disease||Intervention/treatment||Phase|
|Allergic Asthma||Drug: HAE1 (PRO98498)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Official Title:||A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of HAE1 (PRO98498) in Subjects With Moderate to Severe Allergic Asthma|
|Study Start Date :||December 2006|
|Study Completion Date :||September 2007|
- The primary outcome measure is the change from baseline (Visit 1) in total asthma symptom score to Visit 10 (Day 140).
- Incidence and severity of treatment-emergent adverse events and targeted adverse events and incidence of HAE-1 specific antibodies from Visit 1 to the end of the study
- Change from baseline (Visit 1) in asthma symptom scores (nocturnal, morning, daytime, and total) at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140)
- Change from baseline (Visit 1) in the number of puffs per day of beta2-agonist rescue medication at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140)
- The rate of asthma exacerbations at Visit 10
- Change from baseline (Visit 1) in the ACQ at Visits 5, 6, 7, 8, 10, 11, 12, 13, and 14 (Days 28, 56, 84, 112, 140, 168, 196, 224, and 252)
- Change from baseline (Visit 1) in percent predicted forced expiratory volume in 1 second (FEV1) at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406965
|Study Director:||Yamo Deniz, M.D.||Genentech, Inc.|