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Effect of Xolair on Airway Hyperresponsiveness

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Creighton University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00208234
First received: September 14, 2005
Last updated: September 22, 2011
Last verified: September 2011
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208234

Locations
United States, Nebraska
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 School of Medicine
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00208234     History of Changes
Other Study ID Numbers: Xolair Asthma
Study First Received: September 14, 2005
Last Updated: September 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
asthma

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

ClinicalTrials.gov processed this record on November 25, 2014