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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00673218

Enrollment

Registered

2008-05-07

Start date

2007-06-30

Completion date

2012-11-30

Last updated

2012-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergy

Keywords

IL13, Cytokines, Basophil stimulation

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.

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.

Interventions

DRUGPlacebo

Placebo, Q2 or 4 weeks depending on Ige level and weight as appropriate for active treatment.

DRUGXolair

150 to 375 mg is administered SC every 2 or 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Basophil histamine release	After 4 weeks treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026