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Effect of Xolair on Airway Hyperresponsiveness

Sponsor
Creighton University (Other)
Overall Status
Unknown status
CT.gov ID
NCT00208234
Collaborator
Genentech, Inc. (Industry)
22
Enrollment
1
Location
2
Arms
92
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to determine if Xolair can reduce the abnormal increase in limitation to airflow in patients with asthma in a relatively short time period. Another purpose is to determine if Xolair will decrease the amount of inflammation in the lungs of an asthmatic patient in the same time period.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

Xolair, a recombinant humanized monoclonal anti-IgE antibody, has been studied extensively and proven efficacious in the treatment of asthma and other allergic disorders. In moderate to severe allergic asthmatic patients, Xolair reduced asthma exacerbations and improved symptoms. However, there is limited data on the effects of Xolair on airway hyperreactivity, an important component of asthma.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
22 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effects of Xolair (Omalizumab) on Airway Hyperresponsiveness
Study Start Date :
Jan 1, 2004
Anticipated Primary Completion Date :
Sep 1, 2011
Anticipated Study Completion Date :
Sep 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Control

Placebo

Drug: Placebo for Omalizumab
Placebo
Experimental: 2

Omalizumab

Drug: Omalizumab
0.016 mg/kg IgE
Other Names:
  • Xolair
  • rHuMAbE25

    • Drug: omalizumab
    Monoclonal antibody against IgE. 0.016 mg/kg IgE
    Other Names:
  • Xolair
  • rhumabE25

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To determine if treatment with omalizumab induces changes in PC20 values to methacholine bronchoprovocation challenges and/or PC15 values to hypertonic saline-induced bronchoprovocation challenges in a time-dependent manner in steroid naive subjects [post treatment]

    Secondary Outcome Measures

    1. Determine in steroid naive allergic asthma subjects whether omalizumab decreases exhaled NO and sputum eosinophilia, markers of airway inflammation, in time-dependent fashion and to correlate these effects with those measured for airway responsiveness [post treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Female patients must have a negative urine pregnancy test at Visit 1 and a negative urine pregnancy test at subsequent visits. In addition, female patients must be using a medically acceptable form of birth control.

    • History of mild to moderate asthma

    • A positive skin prick test to one or more perennial environmental allergens (dog, cat, dermatophagoides farinae, or dermatophagoides pteronyssinus)

    • A PC20 value for methacholine < 5 mg/mL

    • A PC15 value for hypertonic saline at < 4 minutes

    • Capable of faithfully attending regularly scheduled study visits

    • Willing to avoid prohibited medications for the periods indicated in the protocol

    • A baseline serum IgE level of > 30 IU/mL and < 700 IU/mL

    Exclusion Criteria:

    • Women of childbearing potential not using a medically acceptable form of birth control, as well as women who are breastfeeding

    • Known sensitivity to study drug or class of study drug

    • Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks prior to the screening visit, or for which antibiotic therapy has not been completed at least 2 weeks prior to the screening visit

    • Patients with a history of severe anaphylactoid or anaphylactic reactions

    • Patients taking beta-adrenergic antagonists in any form

    • Patients previously exposed to Xolair

    • Patients with a known hypersensitivity to trial drug excipient ingredients or related drugs

    • Chronic or intermittent use of inhaled, oral, intranasal, intramuscular, or intravenous corticosteroids, or use of topical corticosteroids other than intermittent use of low potency preparations

    • Use of immunosuppressive medications

    • History or presence of significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical condition, including autoimmune or collagen vascular disorders aside from organ-specific autoimmune disease limited to the thyroid that in the investigator's opinion could interfere with the study or require medical treatment that would interfere with the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Creighton University Division of Allergy & Immunology Omaha Nebraska United States 68131

    Sponsors and Collaborators

    • Creighton University
    • Genentech, Inc.

    Investigators

    • Principal Investigator: Thomas B Casale, MD, Creighton University Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Creighton University
    ClinicalTrials.gov Identifier:
    NCT00208234
    Other Study ID Numbers:
    • Xolair Asthma
    First Posted:
    Sep 21, 2005
    Last Update Posted:
    Sep 23, 2011
    Last Verified:
    Sep 1, 2011
    Keywords provided by Creighton University
    asthma
    Additional relevant MeSH terms:
    Respiratory Hypersensitivity
    Omalizumab
    Antibodies, Monoclonal

    Study Results

    No Results Posted as of Sep 23, 2011