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

Sponsor
Creighton University (Other)
Overall Status
Unknown status
CT.gov ID
NCT00673218
Collaborator
Novartis (Industry)
25
Enrollment
1
Location
2
Arms
65.1
Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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
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 Design

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2007
Anticipated Primary Completion Date :
Nov 1, 2012
Anticipated Study Completion Date :
Nov 1, 2012

Arms and Interventions

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 Names:
  • 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 Names:
  • Omalizumab, rhumab-E25

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Basophil histamine release [After 4 weeks treatment]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Creighton University Omaha Nebraska United States 68131

    Sponsors and Collaborators

    • Creighton University
    • Novartis

    Investigators

    • Principal Investigator: Robert G Townley, MD, Creighton University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Creighton University
    ClinicalTrials.gov Identifier:
    NCT00673218
    Other Study ID Numbers:
    • CIGE025AUS22
    First Posted:
    May 7, 2008
    Last Update Posted:
    Jul 6, 2012
    Last Verified:
    Jul 1, 2012
    Keywords provided by Creighton University
    IL13
    Cytokines
    Basophil stimulation
    Additional relevant MeSH terms:
    Omalizumab

    Study Results

    No Results Posted as of Jul 6, 2012