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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00434434 |
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Date of registration:
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11/02/2007 |
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Primary sponsor: |
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Public title:
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A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma
AQUA |
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Scientific title:
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A Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lyophilized and Aged Liquid Omalizumab in the Prevention of Allergen-Induced Airway Obstruction in Adults With Mild Allergic Asthma |
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Date of first enrolment:
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October 2007 |
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Target sample size:
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61 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00434434 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Dennis Wong, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Genentech |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Signed Informed Consent Form
- Meet criteria for the diagnosis of allergic asthma
- Be between the ages of 18 to 65 years
- Have a normal chest X-ray within 2 years of screening
Exclusion Criteria:
- Need 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 omalizumab (e.g., monoclonal antibodies, polyclonal gamma globulin)
- Have a documented medical history of anaphylaxis
- Have lung disease other than mild allergic asthma
- Have taken other investigational drugs within 30 days or 5 half-lives prior to the
screening visit, whichever is longer
- Are unable or unwilling to comply with study procedures and visits
- Are pregnant or lactating
- Have significant medical illness other than asthma, including malignancies, parasitic
infections, immune system disorders, and thrombocytopenia
- Have been treated with omalizumab within 12 months prior to screening
- Currently smoke or have a history of smoking more than 10 pack-years
- Have a history of drug or alcohol abuse, which, in the judgment of the investigator,
may put the subject at risk for being unable to participate fully in the study for
the duration of the study
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Allergic Asthma
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Intervention(s)
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Drug: omalizumab
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Drug: placebo
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Primary Outcome(s)
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Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)
[Time Frame: From baseline to Week 16]
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Secondary Outcome(s)
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Ratio of the Allergen Forced Expiratory Volume at One Second (FEV1) Two-point Slope at the Week 16 Allergen Challenge to the Allergen FEV1 Two-point Slope at the Baseline Allergen Challenge
[Time Frame: From baseline to Week 16]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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