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

This study has been completed.
Information provided by:
Genentech, Inc.
ClinicalTrials.gov Identifier:
First received: February 11, 2007
Last updated: April 30, 2010
Last verified: April 2010
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 Blind (Subject, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00434434

Sponsors and Collaborators
Genentech, Inc.
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 
Study First Received: February 11, 2007
Results First Received: February 17, 2010
Last Updated: April 30, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech, Inc.:

Additional relevant MeSH terms:
Airway Obstruction
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiration Disorders
Respiratory Hypersensitivity
Respiratory Insufficiency
Respiratory Tract Diseases
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on May 23, 2016