This trial is active, not recruiting.

Condition allergy
Treatments placebo, xolair
Phase phase 4
Sponsor Creighton University
Collaborator Novartis
Start date June 2007
End date November 2012
Trial size 25 participants
Trial identifier NCT00673218, CIGE025AUS22


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose basic science
(Placebo Comparator)
Saline injection to match active
placebo Saline
Placebo, Q2 or 4 weeks depending on Ige level and weight as appropriate for active treatment.
Active treatment with Xolair 150 to 375 mg is administered SC every 2 or 4 weeks
xolair Omalizumab, rhumab-E25
150 to 375 mg is administered SC every 2 or 4 weeks

Primary Outcomes

Basophil histamine release
time frame: After 4 weeks treatment

Eligibility Criteria

Male or female participants from 19 years up to 50 years old.

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

Additional Information

Official title The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils
Principal investigator Robert G Townley, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2012.
Information provided to ClinicalTrials.gov by Creighton University.