Effect of Xolair on Airway Hyperresponsiveness

• Status: Unknown status
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Creighton University
• Collaborator: Genentech, Inc.
• Treatments: Antibodies, Monoclonal; Omalizumab

Criteria

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