Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation
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ClinicalTrials.gov Identifier: NCT01631760 |
Recruitment Status :
Withdrawn
First Posted : June 29, 2012
Last Update Posted : October 7, 2014
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Condition or disease | Intervention/treatment |
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Asthma | Genetic: no intervention |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation |
Study Start Date : | October 2011 |
Actual Primary Completion Date : | February 2014 |
Group/Cohort | Intervention/treatment |
---|---|
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.
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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. |
- To evaluate to effect of asthma exacerbation on MiRNA profiling and expression [ Time Frame: August 9, 2014 ]
- To evaluate to effect of asthma exacerbation treatment on miRNA profiling and expression [ Time Frame: August 2014 ]
- 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. [ Time Frame: August 2014 ]

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Ages Eligible for Study: | 5 Years to 85 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631760
United States, Florida | |
USF Asthma, Allergy and Immunology | |
Tampa, Florida, United States, 33613 | |
USF Division of Allergy and Clinical Immunology Clinical Research Unit | |
Tampa, Florida, United States, 33613 |
Principal Investigator: | Richard Lockey, MD | Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine |
Responsible Party: | Richard Lockey, Principal Investigator, University of South Florida |
ClinicalTrials.gov Identifier: | NCT01631760 |
Other Study ID Numbers: |
Biomarkers in Asthma |
First Posted: | June 29, 2012 Key Record Dates |
Last Update Posted: | October 7, 2014 |
Last Verified: | October 2014 |
Asthma Asthma Exacerbations |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |