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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00434434
Other study ID # Q4160g
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 2007
Est. completion date June 2009

Study information

Verified date December 2022
Source Genentech, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This was a multicenter, randomized, double-blind, parallel-group, three-arm, placebo-controlled study designed to demonstrate the efficacy of two different formulations of omalizumab compared with placebo in reducing the airway reaction to an inhaled aeroallergen solution in adult subjects with mild allergic asthma.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date June 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
omalizumab
Aged Liquid; subcutaneous repeating dose
omalizumab
Lyophilized; subcutaneous repeating dose
placebo
Subcutaneous repeating dose

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Genentech, Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1) The primary analysis included two tests: a test for superiority of the lyophilized formulation of omalizumab compared with placebo in the change of allergen concentration and a test for the superiority of the aged liquid omalizumab compared with placebo. The difference for the change in the allergen concentration between the lyophilized formulation of omalizumab and placebo, and between the aged liquid omalizumab and placebo were assessed by the exact Wilcoxon-Mann-Whitney test. From baseline to Week 16
Secondary 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 FEV1 is the volume exhaled during the first second of a forced expiratory maneuver started from the level of total lung capacity, measured in liters. The allergen FEV1 two-point slope is defined as the final percent change in FEV1 from pre-challenge value divided by the final value of allergen concentration used in the challenge. From baseline to Week 16
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