Effect of Xolair on Airway Hyperresponsiveness

Status unconfirmed · Phase 4 · Has a placebo group

Conditions studied: Allergic Asthma

In brief

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.

Key facts

Study ID

NCT00208234

Run by

Creighton University

People needed

22

Starts

2004-01-01

Expected to finish

2011-09-01

Last updated by the study team

2011-09-23

Who can join

Age: 19 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Creighton University Division of Allergy & Immunology — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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