Cell Biology of Steroid Resistant Asthma

NCT ID: NCT00361920

Last Updated: 2017-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2007-03-31

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

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). Unfortunately these patients are subjected to the unwanted side effects (osteoporosis, cataracts, etc) of high dose steroid therapy because non-immune tissues remain sensitive to steroids. Recent studies suggest that the costs of asthma are largely attributable to uncontrolled disease (7). Thus, it is important to understand the mechanism(s) of steroid resistance and introduce new forms of therapy for the treatment of these difficult to control asthmatics. As a prelude to pharmaceutical studies in steroid resistant asthma, it is imperative to develop biomarkers that can robustly identify individuals likely to be poor steroid responders so that alternative non-steroid anti-inflammatory therapies, such as Xolair®, can be introduced early in the course of asthma therapy.

Conditions

Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

prednisone

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

National Jewish Health

OTHER

Sponsor Role: lead

Principal Investigators

Donald Leung, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

National Jewish Health

Locations

National Jewish Medical and Research Center

Denver, Colorado, United States

Countries

United States

Other Identifiers

HS-2034

Identifier Type: -

Identifier Source: org_study_id