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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00434434
First Posted: February 13, 2007
Last Update Posted: May 26, 2010
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.
Information provided by:
Genentech, Inc.
  Purpose
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 Intervention Phase
Allergic Asthma Drug: omalizumab Drug: placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 61
Study Start Date: October 2007
Study Completion Date: June 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00434434


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

Responsible Party: Clinical Trials Posting Group, Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00434434     History of Changes
Other Study ID Numbers: Q4160g
First Submitted: February 11, 2007
First Posted: February 13, 2007
Results First Submitted: February 17, 2010
Results First Posted: May 26, 2010
Last Update Posted: May 26, 2010
Last Verified: April 2010

Keywords provided by Genentech, Inc.:
AQUA
anti-CD11
CD11a
Asthma
Allergy

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