Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation
Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation
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).