Cell Biology of Steroid Resistant Asthma

National Jewish Health

Status: Completed

Conditions: Asthma

Treatments: Drug: prednisone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00361920

HS-2034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)