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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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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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

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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.

Detailed Description

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Conditions

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Allergic Asthma

Keywords

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AQUA anti-CD11 CD11a Asthma Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

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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

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dennis Wong, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Countries

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Canada United States

Other Identifiers

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Q4160g

Identifier Type: -

Identifier Source: org_study_id