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A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-Induced Asthma (AERO)
This study is ongoing, but not recruiting participants.
Sponsored by: Genentech
Information provided by: Genentech
ClinicalTrials.gov Identifier: NCT00495612
  Purpose

This is a three-center, randomized, double-blind, parallel-group, placebo-controlled study with a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with placebo, reduces the degree of bronchoconstriction induced by environmental cat dander exposure in patients 18-65 years old with stable, moderate asthma and a history of cat dander-induced asthma symptoms. A total of approximately 82 patients will be randomized into this study.


Condition Intervention Phase
Asthma
Drug: omalizumab
Drug: placebo
Phase IV

MedlinePlus related topics: Allergy Asthma
Drug Information available for: Omalizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment
Official Title: A Phase IV, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-Induced Asthma

Further study details as provided by Genentech:

Primary Outcome Measures:
  • Percent change in FEV1 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent decrease in FEV1 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Maximum percent change in FEV1 [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Duration of cat chamber exposure [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change in chest symptom score [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Change in nasal and ocular symptom scores (NOSS) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment: 82
Study Start Date: September 2007
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: omalizumab
Subcutaneous injection
2: Placebo Comparator Drug: placebo
Subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed Informed Consent Form
  • 18 to 65 years of age and in general good health
  • History of moderate asthma, defined by the need for routine inhaled corticosteroids for at least the last 90 days prior to screening as well as the routine use of additional medication(s) (e.g., short- or long-acting β2-agonists, leukotriene antagonist, or theophylline) to control asthma symptoms
  • History of cat dander-induced asthma in the 3 years prior to randomization
  • Cat exposure at the time of screening must remain constant throughout the duration of the study (e.g., patients having cat exposure at home must continue to have regular exposure during the study; patients having no cat exposure at home must continue having no exposure at home during the study)
  • Positive skin test to cat allergen, defined as a ≥ 5-mm wheal over the saline control wheal
  • Baseline FEV1 ≥ 70% predicted after withholding long-acting β2-agonists for > 36 hours and short-acting β2-agonists for > 6 hours
  • Eligibility per the study drug dosing table (serum IgE level ≥ 30 to ≤ 700 IU/mL and body weight ≥ 30 to ≤ 150 kg) and ability to be dosed per the dosing table
  • Less than 10 pack-years of smoking history
  • Demonstrated ≥ 20% fall in FEV1 during up to 1 hour of exposure in the cat environmental exposure chamber and ability to withstand exposure for at least 20 minutes

Exclusion Criteria:

  • Unstable asthma (defined as a hospitalization within the prior 6 months or an exacerbation requiring oral corticosteroids within 4 weeks of study entry)
  • Life-threatening episode of asthma in the previous year
  • History of severe allergic reactions to cat exposure
  • Having undergone cat immunotherapy within 6 months prior to screening
  • Upper respiratory infection within 2 weeks of study entry
  • Active lung disease other than asthma
  • Significant medical illness other than asthma, including malignancies, parasitic infections, immune system disorders, and thrombocytopenia
  • 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)
  • Documented medical history of anaphylaxis
  • Receipt of other investigational drugs within 30 days or 5 half-lives prior to screening, whichever is longer
  • Pregnant women and nursing mothers
  • Treatment with omalizumab within 12 months prior to screening
  • History of drug or alcohol abuse that, in the judgment of the investigator, may put the patient at risk for being unable to participate fully in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00495612

Locations
United States, California
Allergy Research Foundation
Los Angeles, California, United States, 90025
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
Canada, Ontario
Cetero-Allied Research Intl
Mississauga, Ontario, Canada, L4W 1N2
Sponsors and Collaborators
Genentech
Investigators
Study Director: James Fish, M.D. Genentech
  More Information

Responsible Party: Genentech, Inc. ( Clinical Trials Posting Group )
Study ID Numbers: Q4229n
Study First Received: June 29, 2007
Last Updated: December 22, 2008
ClinicalTrials.gov Identifier: NCT00495612  
Health Authority: United States: Institutional Review Board

Keywords provided by Genentech:
Xolair
Allergic Asthma
Cat Allergy

Study placed in the following topic categories:
Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Omalizumab
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009