Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation
This study is currently recruiting participants.
Verified January 2013 by University of South Florida
Sponsor:
University of South Florida
Information provided by (Responsible Party):
Richard Lockey, University of South Florida
ClinicalTrials.gov Identifier:
NCT01631760
First received: June 27, 2012
Last updated: January 31, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Asthma |
Genetic: no intervention |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation |
Resource links provided by NLM:
Further study details as provided by University of South Florida:
| Estimated Enrollment: | 60 |
| Study Start Date: | August 2011 |
| Estimated Primary Completion Date: | August 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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.
|
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.
|
|
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.
|
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.
|
|
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.
|
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.
|
Eligibility| Ages Eligible for Study: | 5 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
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.
Criteria
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:
- 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.
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631760
Contacts
| Contact: Michelle Grandstaff-Singleton, LPN | 813-631-4024 ext 201 | mgrandst@health.usf.edu |
Locations
| United States, Florida | |
| USF Division of Allergy and Clinical Immunology Clinical Research Unit | Not yet recruiting |
| Tampa, Florida, United States, 33613 | |
| Contact: Michelle Grandstaff-Singleton, LPN 813-631-4024 ext 201 mgrandst@health.usf.edu | |
| Principal Investigator: Richard Lockey, MD | |
| Sub-Investigator: Michel Alkhalil, MD | |
| Sub-Investigator: Jia-Wang Wang, PhD | |
| Sub-Investigator: Shyam Mohapatra, PhD | |
| USF Asthma, Allergy and Immunology | Recruiting |
| Tampa, Florida, United States, 33613 | |
| Contact: Michelle F Singleton, BHSc 813-631-4024 ext 201 mgrandst@health.usf.edu | |
Sponsors and Collaborators
University of South Florida
Investigators
| Principal Investigator: | Richard Lockey, MD | Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine |
More Information
No publications provided
| Responsible Party: | Richard Lockey, Principal Investigator, University of South Florida |
| ClinicalTrials.gov Identifier: | NCT01631760 History of Changes |
| Other Study ID Numbers: | Biomarkers in Asthma |
| Study First Received: | June 27, 2012 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of South Florida:
|
Asthma Asthma Exacerbations |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013