Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation

University of South Florida2 sites in 1 countryOctober 2011

ConditionsAsthma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Asthma
Sponsor: University of South Florida
Locations: 2
Primary Endpoint: To evaluate to effect of asthma exacerbation on MiRNA profiling and expression
Status: Withdrawn
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

We hypothesize that there is a statistically significant difference in miRNA profiling and expression of subjects with asthma upon its exacerbation compared to patient's baseline level or following effective treatment of an exacerbation of asthma. Therefore, plasma miRNA profiling may provide noninvasive, highly specific and sensitive biomarkers for asthma exacerbation's detection and treatment follow-up.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

February 2014

Last Updated

11 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University of South Florida

Responsible Party

Principal Investigator

Richard Lockey

Principal Investigator

University of South Florida

Eligibility Criteria

Inclusion Criteria

•Literacy: The subject must be able to read and comprehend English. Consent: The subject must have the ability to give informed consent. Type of subject: The subject must be seen in the outpatient setting at one of the clinics staffed by faculty members of the Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine.
•Asthma: The subject must have a history of physician diagnosed asthma for at least 1 year and must have a current exacerbation of asthma requiring oral glucocorticosteroids. Asthma exacerbation is defined below.
•Asthma exacerbation (relapse or de novo) is defined as either:
•An increase of asthma symptoms (cough, wheeze, chest tightness, and /or shortness of breath) that does not resolve within 2 hours after the use of rescue albuterol or corticosteroids and requires a medical visit or
•During a scheduled visit, the subject has acute worsening of asthma symptoms and a reduction of \>20% in peak flow, which in the opinion of the investigator requires treatment with oral glucocorticosteroids.

Exclusion Criteria

•Females who are pregnant or lactating.
•Any other coexistent lung disease (COPD, interstitial lung disease, allergic bronchopulmonary aspergillosis, TB, sarcoidosis).
•Any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbates during the study. The list of conditions/diseases that will result in exclusion if determined to be clinically significant includes, but is not limited to: uncontrolled hypertension; hematological, hepatic, neurological, thyroid, peptic ulcer, or renal disease; immunologic compromise; current malignancy.
•Past or current use of tobacco (\<10 pack year smoking history and no smoking within the last 5 years).