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Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation

Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01631760
Enrollment
0
Registered
2012-06-29
Start date
2011-10-31
Completion date
Unknown
Last updated
2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma, Asthma Exacerbations

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.

Interventions

GENETICno intervention

We 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.

Sponsors

University of South Florida
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
5 Years to 85 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frame
To evaluate to effect of asthma exacerbation on MiRNA profiling and expressionAugust 9, 2014

Secondary

MeasureTime frame
To evaluate to effect of asthma exacerbation treatment on miRNA profiling and expressionAugust 2014

Other

MeasureTime frame
To evaluate the differential expression of miRNA in different age groups ages 5 to 12, 13 to 55 and 56y and older) of asthma patients with exacerbation.August 2014

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026