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

Allergy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00673218
• Other study ID #: CIGE025AUS22
• Status: Active, not recruiting
• Phase: Phase 4
• First received: March 30, 2008
• Last updated: July 3, 2012
• Start date: June 2007
• Est. completion date: November 2012

Study information

• Verified date: July 2012
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergy

Intervention

Drug:
• Placebo
Placebo, Q2 or 4 weeks depending on Ige level and weight as appropriate for active treatment.
• Xolair
150 to 375 mg is administered SC every 2 or 4 weeks

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Creighton University	Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Basophil histamine release		After 4 weeks treatment	No