A Study of Omalizumab in the Prevention of Allergen Induced Airway Obstruction in Adults With Mild Allergic Asthma

Study Overview
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Brief Summary
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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.

Official 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

Conditions
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Allergic Asthma

Intervention / Treatment
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* Drug: omalizumab
* Drug: omalizumab
* Drug: placebo


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: omalizumab<br>* Aged Liquid; subcutaneous repeating dose<br>|
| Experimental: 2<br> | Drug: omalizumab<br>* Lyophilized; subcutaneous repeating dose<br>|
| Placebo Comparator: 3<br> | Drug: placebo<br>* Subcutaneous repeating dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AQUA, anti-CD11, CD11a, Asthma, Allergy