Effect of Xolair on Airway Hyperresponsiveness

Creighton University

Status and phase

Unknown

Phase 4

Conditions

Allergic Asthma

Treatments

Drug: Placebo for Omalizumab

Drug: Omalizumab

Drug: omalizumab

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00208234

Xolair Asthma

Details and patient eligibility

About

The purpose of this study is to determine if Xolair can reduce the abnormal increase in limitation to airflow in patients with asthma in a relatively short time period. Another purpose is to determine if Xolair will decrease the amount of inflammation in the lungs of an asthmatic patient in the same time period.

Full description

Xolair, a recombinant humanized monoclonal anti-IgE antibody, has been studied extensively and proven efficacious in the treatment of asthma and other allergic disorders. In moderate to severe allergic asthmatic patients, Xolair reduced asthma exacerbations and improved symptoms. However, there is limited data on the effects of Xolair on airway hyperreactivity, an important component of asthma.

Enrollment

22 estimated patients

Sex

All

Ages

19 to 50 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female patients must have a negative urine pregnancy test at Visit 1 and a negative urine pregnancy test at subsequent visits. In addition, female patients must be using a medically acceptable form of birth control.
History of mild to moderate asthma
A positive skin prick test to one or more perennial environmental allergens (dog, cat, dermatophagoides farinae, or dermatophagoides pteronyssinus)
A PC20 value for methacholine < 5 mg/mL
A PC15 value for hypertonic saline at < 4 minutes
Capable of faithfully attending regularly scheduled study visits
Willing to avoid prohibited medications for the periods indicated in the protocol
A baseline serum IgE level of > 30 IU/mL and < 700 IU/mL

Exclusion criteria

Women of childbearing potential not using a medically acceptable form of birth control, as well as women who are breastfeeding
Known sensitivity to study drug or class of study drug
Any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection that has not resolved at least 2 weeks prior to the screening visit, or for which antibiotic therapy has not been completed at least 2 weeks prior to the screening visit
Patients with a history of severe anaphylactoid or anaphylactic reactions
Patients taking beta-adrenergic antagonists in any form
Patients previously exposed to Xolair
Patients with a known hypersensitivity to trial drug excipient ingredients or related drugs
Chronic or intermittent use of inhaled, oral, intranasal, intramuscular, or intravenous corticosteroids, or use of topical corticosteroids other than intermittent use of low potency preparations
Use of immunosuppressive medications
History or presence of significant renal, hepatic, neurologic, cardiovascular, hematologic, metabolic, cerebrovascular, respiratory, gastrointestinal, or other significant medical condition, including autoimmune or collagen vascular disorders aside from organ-specific autoimmune disease limited to the thyroid that in the investigator's opinion could interfere with the study or require medical treatment that would interfere with the study