Status:
COMPLETED
Non-invasive Ways to Evaluate Lung Disease After Treatment With Xolair
Lead Sponsor:
Creighton University
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Lung Disease
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief 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.
Detailed Description
Traditional methods of sampling secretions from the lower respiratory tract include sputum collection, sputum induction, and bronchoscopy with bronchoalveolar lavage. They cannot be repeated within a ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00139152
Start Date
September 1 2005
End Date
December 1 2009
Last Update
January 7 2014
Active Locations (2)
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1
Creighton University Division of Allergy & Immunology
Omaha, Nebraska, United States, 68131
2
Albany Medical College
Albany, New York, United States, 12208