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Effect of Xolair on Airway Hyperresponsiveness

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Creighton University.
Recruitment status was:  Active, not recruiting
ClinicalTrials.gov Identifier:
First Posted: September 21, 2005
Last Update Posted: September 23, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Genentech, Inc.
Information provided by (Responsible Party):
Creighton University
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 Intervention Phase
Allergic Asthma Drug: Omalizumab Drug: Placebo for Omalizumab Drug: omalizumab Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Xolair (Omalizumab) on Airway Hyperresponsiveness

Resource links provided by NLM:

Further study details as provided by Creighton University:

Primary Outcome Measures:
  • 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 [ Time Frame: post treatment ]

Secondary Outcome Measures:
  • 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 [ Time Frame: post treatment ]

Estimated Enrollment: 22
Study Start Date: January 2004
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Drug: Placebo for Omalizumab
Experimental: 2
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

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00208234

United States, Nebraska
Creighton University Division of Allergy & Immunology
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Genentech, Inc.
Principal Investigator: Thomas B Casale, MD Creighton University Medical Center
  More Information

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00208234     History of Changes
Other Study ID Numbers: Xolair Asthma
First Submitted: September 14, 2005
First Posted: September 21, 2005
Last Update Posted: September 23, 2011
Last Verified: September 2011

Keywords provided by Creighton University:

Additional relevant MeSH terms:
Respiratory Hypersensitivity
Respiratory Tract Diseases
Hypersensitivity, Immediate
Immune System Diseases
Antibodies, Monoclonal
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Immunologic Factors
Physiological Effects of Drugs