Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to study the effects of Xolair using non-invasive techniques from the expired gas of patients with moderate to severe allergic asthma.

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

Details

• Lead Sponsor: Creighton University
• Collaborator: Novartis Pharmaceuticals
• Treatments: Omalizumab

Criteria

Inclusion Criteria:

• On medium to high dose inhaled corticosteroids either with or without a long acting beta agonist

• Baseline IgE 30-700 IU/mL

• Exhaled nitric oxide greater than 13 ppb

• Positive skin test to at least one of the following perennial allergens: cat, dog, dust mite, cockroach

• Stable asthma at the time of enrollment

Exclusion Criteria:

• Concurrent diseases/conditions, history of other diseases/conditions, with clinically significant uncontrolled systemic disease or a history of such disease (eg, infection, hematological, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinological, or gastrointestinal disease) within previous 3 months

• Upper or lower respiratory tract infection within 6 weeks of screening visit

• Elevated IgE level other than atopy

• Known sensitivity to Xolair

• < 3 months of stable immunotherapy

• Smokers

• Pregnant/nursing women

• Women of childbearing potential who are not practicing medically approved contraceptive methods (eg, oral, subcutaneous, mechanical, or surgical contraception) including abstinence

• Patients who currently hav diagnosed cancer, are currently being investigated for possible cancer or who have any history of cancer

• Known sensitivity to study drug or class of study drugs

• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study

• Use of any other investigational agent in the last 30 days.