Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation



Status:Recruiting
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:5 - 85
Updated:11/8/2014
Start Date:August 2011
Contact:Michelle Grandstaff-Singleton, LPN
Email:mgrandst@health.usf.edu
Phone:813-631-4024

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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.


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:

1. 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

2. 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).
We found this trial at
2
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Tampa, Florida 33613
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