Back to resultsCell Biology of Steroid Resistant Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
prednisone
Sponsored by
About this trial
This is an interventional diagnostic trial for Asthma focused on measuring steroid resistant asthma
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- National Jewish Medical and Research Center
Outcomes
Primary Outcome Measures
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
Assess whether DEX-induced MKP-1 mRNA levels are decreased in PBMC or whole blood cells of SR, as compared to SS, asthmatics
Determine whether T cells from SR vs SS asthmatics proliferate in the presence of increasing concentrations of DEX
Determine whether DEX inhibits IL-6, TNF alpha, and IL-13 secretion in PBMC of SR, as compared to SS, asthmatics
Examine expression of GCR-beta and GCR alpha mRNA in PBMC of SR, as compared to SS, asthmatics, T
Analyze PBMC isolated from heparinized blood stored for 18 hours overnight at room temperature for specific aims A through D.
Secondary Outcome Measures
Full Information
NCT ID
NCT00361920
First Posted
August 7, 2006
Last Updated
March 27, 2017
Sponsor
National Jewish Health
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00361920
Brief Title
Cell Biology of Steroid Resistant Asthma
Official Title
Investigating Biomarkers of Steroid Resistant Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Jewish Health
Collaborators
Genentech, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
steroid resistant asthma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
prednisone
Primary Outcome Measure Information:
Title
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
Title
Assess whether DEX-induced MKP-1 mRNA levels are decreased in PBMC or whole blood cells of SR, as compared to SS, asthmatics
Title
Determine whether T cells from SR vs SS asthmatics proliferate in the presence of increasing concentrations of DEX
Title
Determine whether DEX inhibits IL-6, TNF alpha, and IL-13 secretion in PBMC of SR, as compared to SS, asthmatics
Title
Examine expression of GCR-beta and GCR alpha mRNA in PBMC of SR, as compared to SS, asthmatics, T
Title
Analyze PBMC isolated from heparinized blood stored for 18 hours overnight at room temperature for specific aims A through D.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Leung, MD,PhD
Organizational Affiliation
National Jewish Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Jewish Medical and Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Cell Biology of Steroid Resistant Asthma
We'll reach out to this number within 24 hrs