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

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.

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Key information

Conditions

Allergic Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omalizumab

Drug

Aged Liquid; subcutaneous repeating dose

Placebo

Drug

Subcutaneous repeating dose

Primary outcomes

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 outcomes

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.

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study 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

Acronym: AQUA

Important dates

Study start: 2007
Primary completion: 2009
Study completion: 2009
First posted: Feb 13, 2007
Registry last updated: Dec 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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