Cell Biology of Steroid Resistant Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00361920
Recruitment Status : Completed
First Posted : August 9, 2006
Last Update Posted : March 29, 2017
Genentech, Inc.
Information provided by:
National Jewish Health

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: prednisone Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Investigating Biomarkers of Steroid Resistant Asthma
Study Start Date : August 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Prednisone

Primary Outcome Measures :
  1. Assess the prevalence of steroid resistance and to determine what fraction of steroid resistant subjects have positive skin tests and IgE levels ≥30 IU/ml
  2. Assess whether DEX-induced MKP-1 mRNA levels are decreased in PBMC or whole blood cells of SR, as compared to SS, asthmatics
  3. Determine whether T cells from SR vs SS asthmatics proliferate in the presence of increasing concentrations of DEX
  4. Determine whether DEX inhibits IL-6, TNF alpha, and IL-13 secretion in PBMC of SR, as compared to SS, asthmatics
  5. Examine expression of GCR-beta and GCR alpha mRNA in PBMC of SR, as compared to SS, asthmatics, T
  6. Analyze PBMC isolated from heparinized blood stored for 18 hours overnight at room temperature for specific aims A through D.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   12 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00361920

United States, Colorado
National Jewish Medical and Research Center
Denver, Colorado, United States, 80206
Sponsors and Collaborators
National Jewish Health
Genentech, Inc.
Principal Investigator: Donald Leung, MD,PhD National Jewish Health Identifier: NCT00361920     History of Changes
Other Study ID Numbers: HS-2034
First Posted: August 9, 2006    Key Record Dates
Last Update Posted: March 29, 2017
Last Verified: March 2017

Keywords provided by National Jewish Health:
steroid resistant asthma

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents