Cell Biology of Steroid Resistant Asthma

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

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 steroids than patients who are steroid sensitive. These altered responses are the reason they demonstrate steroid resistance.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Jewish Health
• Collaborator: Genentech, Inc.
• Treatments: Prednisone

Criteria

Inclusion Criteria:

1. Will meet American Thoracic Society criteria for asthma

2. 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.

3. Subjects must be 12 to 65 years old.

Exclusion Criteria:

1. Viral infection within four weeks of the starting date.

2. Abnormal hepatic function.

3. History of COPD

4. Pregnancy.

5. History of smoking.

6. Anemia (hemoglobin less than 12 gm %)

7. Concurrent therapy with anticonvulsants, erythromycin, rifampin and any systemic asthma medication including Singular®, Xolair® or oral prednisone.

8. Greater than 500 mcg per day of inhaled corticosteroids

9. Suspected non-compliance with medical care.

10. Abnormal prednisone pharmacokinetics (applies to phase 2 of trial)

11. Patients with severe medical conditions that in the view of the investigator prohibits participation in the study (specify as required)

12. Use of any investigational agent in the last 30 days