The Effect of Xolair (Omalizumab) on Allergy Blood Cells

NCT00657891 | Completed Phase 4

• 1 other identifier: IgE 025 US22
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

We are studying Xolair (omalizumab) to see it's effect on allergic blood cells. The blood tests will be done in a test tube to see if they react differently before and after treatment. The blood cells will be mixed with to whatever the person is allergic.

Conditions

Asthma

Keywords

Allergic Asthma; Anti IgE; Xolair; Basophil; IL-13; IL-4; Histamine

Outcome Measures

Primary Outcomes (1)

• To determine if Xolair (omalizumab) inhibits basophil leukotriene secretion & to compare this with its inhibition of histamine release. We will also compare this inhibition in basophils stimulated with allergen vs anti-IgE vs calcium ionophore.

  1 year

Secondary Outcomes (1)

• To determine the effect of Xolair (omalizumab) on IL-4 &vIL-13 secretion. To compare the effect of Xolair on IL-4 vs IL-13 secretion from basophils stimulated with allergen, anti-IgE & calcium ionophore (ionomycin).

  1 year

Study Arms (2)

1

PLACEBO COMPARATOR

Placebo Injection

Drug: Placebo

2

EXPERIMENTAL

Xolair at 0.016 mg/kg/IgE(iu/ml)/4 wks

Drug: Omalizumab

Interventions

Omalizumab DRUG

0.016 mg/kg/IgE(iU/ml)/4 wks, Subcutaneously

Also known as: Xolair, rhumabe35

2

Placebo DRUG

Placebo Injection

1

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• year history of ragweed allergic rhinitis
• positive skin prick tests to ragweed \>5 mm wheal diameter
• serum IgE \<700 iU/m

You may not qualify if:

• 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 1 week
• 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

Sponsors & Collaborators

• Creighton University: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Creighton University Medical Center

Omaha, Nebraska, 68131, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Omalizumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Robert G Townley, MD

  Creighton University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2008
• First Posted: April 14, 2008
• Study Start: March 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: October 1, 2013

Record last verified: 2013-09

Locations

US (1)