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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Creighton University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00673218
First received: March 30, 2008
Last updated: July 3, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Allergy
Drug: Placebo
Drug: Xolair
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Basophil histamine release [ Time Frame: After 4 weeks treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: June 2007
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   19 Years to 50 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00673218     History of Changes
Other Study ID Numbers: CIGE025AUS22
Study First Received: March 30, 2008
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
IL13
Cytokines
Basophil stimulation

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

ClinicalTrials.gov processed this record on September 30, 2014