Cell Biology of Steroid Resistant Asthma

NCT00361920 | Completed

• 1 other identifier: HS-2034
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

steroid resistant asthma

Outcome Measures

Primary Outcomes (6)

• 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.

Interventions

prednisone DRUG

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Jewish Health: lead
• Genentech, Inc.: collaborator

Study Sites (1)

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

MeSH Terms

Conditions

Asthma

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Donald Leung, MD,PhD

  National Jewish Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 7, 2006
• First Posted: August 9, 2006
• Study Start: August 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: March 1, 2007
• Last Updated: March 29, 2017

Record last verified: 2017-03

Locations

US (1)