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Asthma | Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation

Asthma research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Asthma

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Genetic:no interventionWe will be analyzing MicroRNA in subjects with Asthma Exacerbations by various age groups, Ages 5-12yrs, 13-55yrs, and 56-85yrs for genetic similarities and differences.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

MicroRNA ages 5-12 yrs oldAs a prospective study, we would like to look for the differential expression of microRNA in different age groups (ages 5 to 12, 13 to 55, and 56 and older) of asthma patients with exacerbation. At least 20 patients for each group is anticipated.

MicroRNA ages 13-55 yrs oldAs a prospective study, we would like to look for the differential expression of microRNA in different age groups (ages 5 to 12, 13 to 55, and 56 and older) of asthma patients with exacerbation. At least 20 patients for each group is anticipated.

MicroRNA ages 56-85 yrs oldAs a prospective study, we would like to look for the differential expression of microRNA in different age groups (ages 5 to 12, 13 to 55, and 56 and older) of asthma patients with exacerbation. At least 20 patients for each group is anticipated.

Study Status

Withdrawn

Start Date: October 2011

Completed Date:

Phase:

Type: Observational

Design:

Primary Outcome: To evaluate to effect of asthma exacerbation on MiRNA profiling and expression

Secondary Outcome: To evaluate to effect of asthma exacerbation treatment on miRNA profiling and expression

Study sponsors, principal investigator, and references

Principal Investigator: Richard Lockey, MD

Lead Sponsor: University of South Florida

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01631760

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