Status:
COMPLETED
Cell Biology of Steroid Resistant Asthma
Lead Sponsor:
National Jewish Health
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Asthma
Eligibility:
All Genders
12-65 years
Phase:
NA
Brief Summary
The hypothesis is that patients who demonstrate steroid resistant asthma by showing little or no improvement in lung function after a course of oral steroids have different cellular responses to stero...
Detailed Description
Current NHLBI guidelines for persistent asthma management recommends the use of steroids for treatment of airway inflammation (1,2). However, some asthmatics do not respond to steroids (3-6). Unfortun...
Eligibility Criteria
Inclusion
- Will meet American Thoracic Society criteria for asthma
- Pulmonary function tests consistent with asthma. This includes a baseline FEV1 \< 80% predicted as well as a 12% improvement in FEV1 following up to 4 puffs of albuterol.
- Subjects must be 12 to 65 years old.
Exclusion
- Viral infection within four weeks of the starting date.
- Abnormal hepatic function.
- History of COPD
- Pregnancy.
- History of smoking.
- Anemia (hemoglobin less than 12 gm %)
- Concurrent therapy with anticonvulsants, erythromycin, rifampin and any systemic asthma medication including Singular®, Xolair® or oral prednisone.
- Greater than 500 mcg per day of inhaled corticosteroids
- Suspected non-compliance with medical care.
- Abnormal prednisone pharmacokinetics (applies to phase 2 of trial)
- Patients with severe medical conditions that in the view of the investigator prohibits participation in the study (specify as required)
- Use of any investigational agent in the last 30 days
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00361920
Start Date
August 1 2006
End Date
March 1 2007
Last Update
March 29 2017
Active Locations (1)
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1
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206