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Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Richard Lockey, University of South Florida
ClinicalTrials.gov Identifier:
NCT01631760
First received: June 27, 2012
Last updated: October 6, 2014
Last verified: October 2014
  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

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • To evaluate to effect of asthma exacerbation on MiRNA profiling and expression [ Time Frame: August 9, 2014 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate to effect of asthma exacerbation treatment on miRNA profiling and expression [ Time Frame: August 2014 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: October 2011
Primary Completion Date: February 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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01631760

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

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: October 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Asthma
Asthma Exacerbations

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014