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

Primary Purpose

Allergic Asthma

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

omalizumab

placebo

About this trial

This is an interventional treatment trial for Allergic Asthma focused on measuring AQUA, anti-CD11, CD11a, Asthma, Allergy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)

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

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.

Full Information

NCT ID

NCT00434434

First Posted

February 11, 2007

Last Updated

December 9, 2022

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00434434

Brief Title

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

Acronym

AQUA

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 Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

February 2009 (Actual)

Study Completion Date

June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Asthma

Keywords

AQUA, anti-CD11, CD11a, Asthma, Allergy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

omalizumab

Intervention Description

Aged Liquid; subcutaneous repeating dose

Intervention Type

Drug

Intervention Name(s)

omalizumab

Intervention Description

Lyophilized; subcutaneous repeating dose

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

Subcutaneous repeating dose

Primary Outcome Measure Information:

Title

Change in Logarithmically Transformed (log2) Allergen PC15 Concentration (Allergen Concentration Required to Evoke a 15% Decrease in FEV1)

Description

Time Frame

From baseline to Week 16

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

From baseline to Week 16

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dennis Wong, M.D.

Organizational Affiliation

Genentech, Inc.

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

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

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