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

NCT ID: NCT01698983

Last Updated: 2012-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jeanette Marketon, MD

OTHER

Sponsor Role lead

Responsible Party

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Jeanette Marketon, MD

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jeanette Marketon, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Recruit and Consent Patients

Locations

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Martha Morehouse Medical Pavillion

Columbus, Ohio, United States

Site Status

Martha Morehouse Medical Pavillion

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2011H0055

Identifier Type: -

Identifier Source: org_study_id