Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation
1 other identifier
observational
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 27, 2012
CompletedFirst Posted
Study publicly available on registry
June 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedOctober 7, 2014
October 1, 2014
2.3 years
June 27, 2012
October 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate to effect of asthma exacerbation on MiRNA profiling and expression
August 9, 2014
Secondary Outcomes (1)
To evaluate to effect of asthma exacerbation treatment on miRNA profiling and expression
August 2014
Other Outcomes (1)
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
Study Arms (3)
MicroRNA ages 5-12 yrs old
As 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 old
As 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 old
As 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.
Interventions
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.
Eligibility Criteria
Both genders of any racial or ethnic group, age 5-85 are eligible. The subjects should not have participated in any other experimental study in the last 30 days.
You may qualify if:
- 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:
- 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
- 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.
You may not qualify if:
- Females who are pregnant or lactating.
- Any other coexistent lung disease (COPD, interstitial lung disease, allergic bronchopulmonary aspergillosis, TB, sarcoidosis).
- Past or current use of tobacco (\<10 pack year smoking history and no smoking within the last 5 years).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
USF Asthma, Allergy and Immunology
Tampa, Florida, 33613, United States
USF Division of Allergy and Clinical Immunology Clinical Research Unit
Tampa, Florida, 33613, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Lockey, MD
Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 27, 2012
First Posted
June 29, 2012
Study Start
October 1, 2011
Primary Completion
February 1, 2014
Last Updated
October 7, 2014
Record last verified: 2014-10