Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation

Asthma Clinical Trial

Official title:

Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01631760
• Other study ID #: Biomarkers in Asthma
• Status: Withdrawn
• Phase: N/A
• First received: June 27, 2012
• Last updated: October 6, 2014
• Start date: October 2011

Study information

• Verified date: October 2014
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 85 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma

Intervention

Genetic:
• no 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.

Locations

Country	Name	City	State
United States	USF Asthma, Allergy and Immunology	Tampa	Florida
United States	USF Division of Allergy and Clinical Immunology Clinical Research Unit	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	To evaluate to effect of asthma exacerbation on MiRNA profiling and expression		August 9, 2014	No
Secondary	To evaluate to effect of asthma exacerbation treatment on miRNA profiling and expression		August 2014	No