Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation

• ClinicalTrials.gov Identifier: NCT01631760
• Recruitment Status: Withdrawn
• First Posted: June 29, 2012
• Last Update Posted: October 7, 2014
• Sponsor: University of South Florida
• Information provided by (Responsible Party): Richard Lockey, University of South Florida

Study Description

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.

Condition or disease	Intervention/treatment
Asthma	Genetic: no intervention

Study Design

• 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

Groups and Cohorts

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.	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.

Outcome Measures

Primary Outcome Measures :

1. To evaluate to effect of asthma exacerbation on MiRNA profiling and expression [ Time Frame: August 9, 2014 ]

Secondary Outcome Measures :

1. To evaluate to effect of asthma exacerbation treatment on miRNA profiling and expression [ Time Frame: August 2014 ]

Other Outcome Measures:

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. [ Time Frame: August 2014 ]

Eligibility Criteria

• 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

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:

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).

Contacts and Locations

Locations

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

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

• 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
• Last Update Posted: October 7, 2014
• Last Verified: October 2014

Keywords provided by Richard Lockey, 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