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The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils

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ClinicalTrials.gov Identifier: NCT00673218
Recruitment Status : Unknown
Verified July 2012 by Creighton University.
Recruitment status was:  Active, not recruiting
First Posted : May 7, 2008
Last Update Posted : July 6, 2012
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Creighton University

Brief Summary:
If you are allergic to ragweed, and not taking certain medications, you will be asked to have blood drawn. We will perform experiments on your blood cells.

Condition or disease Intervention/treatment Phase
Allergy Drug: Placebo Drug: Xolair Phase 4

Detailed Description:
Adult ragweed allergic subjects will have blood drawn. Basophils will be enriched and stimulated with allergen and controls. Supernatants from these stimulations will be assayed for cytokines and histamine.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
Study Start Date : June 2007
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Arm Intervention/treatment
Placebo Comparator: 1
Saline injection to match active
Drug: Placebo
Placebo, Q2 or 4 weeks depending on Ige level and weight as appropriate for active treatment.
Other Name: Saline

Experimental: Treatment
Active treatment with Xolair 150 to 375 mg is administered SC every 2 or 4 weeks
Drug: Xolair
150 to 375 mg is administered SC every 2 or 4 weeks
Other Name: Omalizumab, rhumab-E25




Primary Outcome Measures :
  1. Basophil histamine release [ Time Frame: After 4 weeks treatment ]


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

Inclusion Criteria:

  • Ages 19 to 50
  • At least 2 year history of ragweed allergic rhinitis
  • Positive skin prick tests to ragweed >5 mm wheal diameter
  • IgE <700 iU/m

Exclusion Criteria:

  • Use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 2 days.
  • History of immunotherapy in the past 2 years
  • Exposure to Omalizumab in the past 2 years
  • Clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens
  • Asthma other than mild intermittent
  • Women of childbearing potential who are not on an accepted form of birth control, as well as women who are breastfeeding
  • Known sensitivity to study drug Xolair
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  • Patients with a previous history of cancer
  • Use of any other investigational agent in the last 30 days

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): NCT00673218


Locations
United States, Nebraska
Creighton University
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Novartis
Investigators
Principal Investigator: Robert G Townley, MD Creighton University

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00673218     History of Changes
Other Study ID Numbers: CIGE025AUS22
First Posted: May 7, 2008    Key Record Dates
Last Update Posted: July 6, 2012
Last Verified: July 2012

Keywords provided by Creighton University:
IL13
Cytokines
Basophil stimulation

Additional relevant MeSH terms:
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents