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

Phase 2

Completed

• Conditions: Allergic Asthma
• Interventions: Drug: omalizumab; Drug: placebo

• Registration Number: NCT00434434
• Lead Sponsor: Genentech, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-11
• Study First Submitted QC: 2007-02-11
• Study First Posted: 2007-02-13
• Study Start: 2007-10
• Primary Completion: 2009-02
• Study Completion: 2009-06
• Results First Submitted: 2010-02-17
• Results First Submitted QC: 2010-04-30
• Results First Posted: 2010-05-26
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	omalizumab	-
2	omalizumab	-
3	placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)	From baseline to Week 16	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.

Secondary Outcome Measures

Name	Time	Method
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	From baseline to Week 16	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.