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

NCT00434434 | Completed Phase 2 Results

• 1 other identifier: Q4160g
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Allergic Asthma

Keywords

AQUA; anti-CD11; CD11a; Asthma; Allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  From baseline to Week 16

Study Arms (3)

1

EXPERIMENTAL

Drug: omalizumab

2

EXPERIMENTAL

Drug: omalizumab

3

PLACEBO COMPARATOR

Drug: placebo

Interventions

omalizumab DRUG

Aged Liquid; subcutaneous repeating dose

1

placebo DRUG

Subcutaneous repeating dose

3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Asthma; Hypersensitivity

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

800-821-8590

Study Officials

• Dennis Wong, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2007
• First Posted: February 13, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: June 1, 2009
• Last Updated: December 14, 2022
• Results First Posted: May 26, 2010

Record last verified: 2022-12