Status:
COMPLETED
A Study to Evaluate MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma
Lead Sponsor:
Genentech, Inc.
Conditions:
Allergic Asthma
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This is a multicenter, randomized, double-blind, placebo-controlled study designed to demonstrate the safety and efficacy of MILR1444A compared with placebo in reducing the airway reaction to an inhal...
Eligibility Criteria
Inclusion
- Meet criteria for the diagnosis of allergic asthma
- Diagnosis of asthma ≥ 6 months
- Currently treated with only intermittent short-acting inhaled β-adrenergic agonists
- Body weight between 40-120 kg
- Normal chest X-ray within 2 years of screening
Exclusion
- Require daily controller medication for asthma
- History of hypersensitivity to the study drug or to drugs with similar chemical structures or to any ingredients, including excipients of the study medication or drugs related to MILR1444A (e.g., monoclonal antibodies, polyclonal gamma globulin)
- Documented medical history of anaphylaxis
- Immunotherapy currently or within the past 3 months prior to screening
- Lung disease other than mild allergic asthma
- Previous treatment with other investigational drugs within 30 days or 5 half-lives prior to the screening visit, whichever is longer
- Pregnant or lactating
- Significant concurrent medical illness other than asthma
- Clinically significant abnormality on ECG at the screening visit
- Smoked in the previous 6 months or have a history of smoking more than 10 pack-years
- History of helminthic infection
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00781443
Start Date
December 1 2008
Last Update
May 6 2010
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