Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics

This study has been terminated.
(data not as expected)
Sponsor:
Information provided by (Responsible Party):
Jeanette Marketon, MD, The Ohio State University
ClinicalTrials.gov Identifier:
NCT01698983
First received: October 1, 2012
Last updated: October 30, 2012
Last verified: October 2012
  Purpose

Gluococorticoids are commonly prescribed to treat a number of diseases including the majority of inflammatory diseases. Despite considerable inter-personal variability in responses to glucocorticoids between asthmatics, an insensitivity rate of about 30% and the risk of adverse side effects of glucocorticoid therapy, no assay is currently performed to determine sensitivity in severe and non-severe asthmatics prior to treatment. The purpose of this study is to perform a whole blood ex vivo stimulation assay to interrogate known glucocorticoid receptor (GR) up- and down-regulated genes to indicate glucocorticoid sensitivity and compare the results between severe and non-severe asthmatics.


Condition
Asthma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ex Vivo Stimulation of Whole Blood as a Means to Determine Glucocorticoid Sensitivity to Mild-to-Moderate and Refractory Asthmatics

Resource links provided by NLM:


Further study details as provided by Ohio State University:

Enrollment: 14
Study Start Date: June 2011
Study Completion Date: October 2012
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

clinic

Criteria

Inclusion criteria:

To be eligible for the study, subjects must meet all of the following criteria:

  • Age ≥ 18 years old
  • Physician diagnosis of asthma confirmed through medical record documentation.
  • Documented history of 12% FEV1 reversibility post-bronchodilator and/or Methacholine PC 20 score of 16mg/ml or less.
  • Non-smoker for > 6 months before enrollment into the trial
  • Less than 5 pack year smoking history defined as the average packs smoked per day multiplied by the years of active smoking.
  • Willing and able to adhere to the study visit schedule and other protocol-specified procedures.

Exclusion criteria:

Subjects meeting any of the following criteria may not be enrolled in the study:

  • Existence of lung disease (other than asthma)
  • Recent asthma exacerbation requiring hospital admissions, unexpected healthcare visits, or prednisone courses in the previous 4 weeks.
  • Non-English speaking.
  • Participation in another interventional research trial
  • Self-reported pregnancy
  • Inability or unwillingness to provide consent
  • Febrile illness (>38.0˚ C or 100.4˚ F) within 24 hours of visit.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01698983

Locations
United States, Ohio
Martha Morehouse Medical Pavillion
Columbus, Ohio, United States, 43221
Martha Morehouse Medical Pavillion
Columbus, Ohio, United States, 432211
Sponsors and Collaborators
Jeanette Marketon, MD
Investigators
Principal Investigator: Jeanette Marketon, Ph.D. Recruit and Consent Patients
  More Information

No publications provided

Responsible Party: Jeanette Marketon, MD, Assistant Professor, The Ohio State University
ClinicalTrials.gov Identifier: NCT01698983     History of Changes
Other Study ID Numbers: 2011H0055
Study First Received: October 1, 2012
Last Updated: October 30, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014