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Sponsored by: |
Genentech |
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Information provided by: | Genentech |
ClinicalTrials.gov Identifier: | NCT00781443 |
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 inhaled aeroallergen solution in adult patients with mild allergic asthma. The study will randomize approximately 24 patients at five study centers. In the event of patient discontinuation from the study, additional patients may be enrolled at the discretion of the Sponsor.
Condition | Intervention | Phase |
---|---|---|
Allergic Asthma |
Drug: MILR1444A Drug: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment |
Official Title: | A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MILR1444A in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma |
Estimated Enrollment: | 24 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
A: Experimental |
Drug: MILR1444A
Repeating subcutaneous injection
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B: Placebo Comparator |
Drug: placebo
Repeating subcutaneous injection
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Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Todd Clobes | clobes.todd@gene.com |
Study Director: | June Lee, M.D. | Genentech |
Responsible Party: | Genentech, Inc. ( Clinical Trials Posting Group ) |
Study ID Numbers: | ILR4544g |
Study First Received: | October 27, 2008 |
Last Updated: | October 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00781443 |
Health Authority: | United States: Food and Drug Administration |
Asthma |
Hypersensitivity Lung Diseases, Obstructive Respiratory Insufficiency Respiratory Tract Diseases Lung Diseases |
Respiration Disorders Hypersensitivity, Immediate Asthma Airway Obstruction Respiratory Hypersensitivity |
Immune System Diseases Bronchial Diseases |