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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00434434
Recruitment Status : Completed
First Posted : February 13, 2007
Results First Posted : May 26, 2010
Last Update Posted : May 26, 2010
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Allergic Asthma Drug: omalizumab Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2007
Actual Primary Completion Date : February 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Choking
Drug Information available for: Omalizumab

Arm Intervention/treatment
Experimental: 1 Drug: omalizumab
Aged Liquid; subcutaneous repeating dose

Experimental: 2 Drug: omalizumab
Lyophilized; subcutaneous repeating dose

Placebo Comparator: 3 Drug: placebo
Subcutaneous repeating dose

Primary Outcome Measures :
  1. Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1) [ Time Frame: 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 :
  1. 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 [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00434434

Sponsors and Collaborators
Genentech, Inc.
Study Director: Dennis Wong, M.D. Genentech, Inc.

Responsible Party: Clinical Trials Posting Group, Genentech, Inc. Identifier: NCT00434434     History of Changes
Other Study ID Numbers: Q4160g
First Posted: February 13, 2007    Key Record Dates
Results First Posted: May 26, 2010
Last Update Posted: May 26, 2010
Last Verified: April 2010

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Airway Obstruction
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Respiratory Insufficiency
Respiration Disorders
Antibodies, Monoclonal
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Immunologic Factors
Physiological Effects of Drugs