Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 7:15 PM
Study NCT ID:
NCT01631760
Status:
WITHDRAWN
Last Update Posted:
2014-10-07
First Post:
2012-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-06', 'studyFirstSubmitDate': '2012-06-27', 'studyFirstSubmitQcDate': '2012-06-27', 'lastUpdatePostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '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.', 'timeFrame': 'August 2014'}], 'primaryOutcomes': [{'measure': 'To evaluate to effect of asthma exacerbation on MiRNA profiling and expression', 'timeFrame': 'August 9, 2014'}], 'secondaryOutcomes': [{'measure': 'To evaluate to effect of asthma exacerbation treatment on miRNA profiling and expression', 'timeFrame': 'August 2014'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Asthma Exacerbations'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n\nAsthma exacerbation (relapse or de novo) is defined as either:\n\n1. 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\n2. 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.\n\nExclusion Criteria:\n\n* Females who are pregnant or lactating.\n* Any other coexistent lung disease (COPD, interstitial lung disease, allergic bronchopulmonary aspergillosis, TB, sarcoidosis).\n* 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.\n* Past or current use of tobacco (\\<10 pack year smoking history and no smoking within the last 5 years).'}, 'identificationModule': {'nctId': 'NCT01631760', 'briefTitle': 'Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Identification of Plasma miRNAs as Potential Biomarkers in Asthma Exacerbation', 'orgStudyIdInfo': {'id': 'Biomarkers in Asthma'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MicroRNA ages 5-12 yrs old', 'description': '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.', 'interventionNames': ['Genetic: no intervention']}, {'label': 'MicroRNA ages 13-55 yrs old', 'description': '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.', 'interventionNames': ['Genetic: no intervention']}, {'label': 'MicroRNA ages 56-85 yrs old', 'description': '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.', 'interventionNames': ['Genetic: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'GENETIC', 'description': '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.', 'armGroupLabels': ['MicroRNA ages 13-55 yrs old', 'MicroRNA ages 5-12 yrs old', 'MicroRNA ages 56-85 yrs old']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'USF Asthma, Allergy and Immunology', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'USF Division of Allergy and Clinical Immunology Clinical Research Unit', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Richard Lockey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Division of Allergy and Immunology, Department of Internal Medicine, University of South Florida College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Richard Lockey', 'investigatorAffiliation': 'University of South Florida'}}}}