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

Allergic Asthma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00434434
• Other study ID #: Q4160g
• Status: Completed
• Phase: Phase 2
• Start date: October 2007
• Est. completion date: June 2009

Study information

• Verified date: December 2022
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: June 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Airway Obstruction
• Allergic Asthma
• Asthma

Intervention

Drug:
• omalizumab
Aged Liquid; subcutaneous repeating dose
• omalizumab
Lyophilized; subcutaneous repeating dose
• placebo
Subcutaneous repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to Week 16
Secondary	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.	From baseline to Week 16