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

NCT ID: NCT00434434

Last Updated: 2022-12-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-06-30

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.

Conditions

Allergic Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Group Type: EXPERIMENTAL

omalizumab

Intervention Type: DRUG

Aged Liquid; subcutaneous repeating dose

2

Group Type: EXPERIMENTAL

omalizumab

Intervention Type: DRUG

Lyophilized; subcutaneous repeating dose

3

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Subcutaneous repeating dose

Interventions

omalizumab

Aged Liquid; subcutaneous repeating dose

Intervention Type: DRUG

omalizumab

Lyophilized; subcutaneous repeating dose

Intervention Type: DRUG

placebo

Subcutaneous repeating dose

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dennis Wong, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Other Identifiers

Q4160g

Identifier Type: -

Identifier Source: org_study_id