Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-02-23 @ 4:31 AM
Study NCT ID:
NCT01690793
Status:
COMPLETED
Last Update Posted:
2015-05-28
First Post:
2010-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples of blood will be secured in the Division of Allergy/Immunology at the University of South Florida, Joy McCann Culverhouse Airways Disease Center. All samples will be appropriately coded to maintain confidentiality. Blood specimens will be held at minus 20 degrees Celsius. GENETICS SAMPLES ARE OPTIONAL'}, 'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2010-08-05', 'studyFirstSubmitQcDate': '2012-09-18', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The measurement of NHPs after treatment of an exacerbation of asthma', 'timeFrame': '14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ASTHMA', 'ACUTE EXACERBATION OF ASTHMA'], 'conditions': ['ASTHMA']}, 'descriptionModule': {'briefSummary': 'The investigators hypothesize that there is a statistically significant decrease of Natriuretic Hormone Peptides (NHPs) in subjects with asthma exacerbation compared to levels following treatment of an exacerbation of asthma.', 'detailedDescription': 'Overall Study Design\n\n1. Measurement of Natriuretic Hormone Peptides in individuals suffering from exacerbation of asthma.\n2. Measurement of Natriuretic Hormone Peptides 5-7 days after initiation of treatment of exacerbation of asthma.\n3. Measurement of Natriuretic Hormone Peptides 10-14 days after initiation of treatment of exacerbation of asthma.\n\n3 comparisons of Natriuretic Hormone Peptides levels will be made:\n\n1. Exacerbation compared to 5-7 days after initiation of treatment\n2. Exacerbation compared to 10-14 days after initiation of treatment\n3. 5-7 days after initiation of treatment compared to 10-14 days after initiation of treatment.\n\nSamples of blood will be secured in the Division of Allergy/Immunology at the University of South Florida, Joy McCann Culverhouse Airways Disease Center. All samples will be appropriately coded to maintain confidentiality. Blood specimens will be held at minus 20 degrees Celsius.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The Asthma Control Test score of less than 18.\n\nAsthma control test consists of five questions, scored 1-5 each.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Both genders, age 18-85.\n* Females who are pregnant or lactating are not eligible.\n* Read and comprehend English.\n* Ability to give informed consent.\n* Seen in the outpatient setting at one of the clinic.\n* The subject must have a history of physician diagnosed asthma for at least 1 year and must have an exacerbation of asthma for entry into the study.'}, 'identificationModule': {'nctId': 'NCT01690793', 'acronym': 'acute asthma', 'briefTitle': 'Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma', 'organization': {'class': 'OTHER', 'fullName': 'University of South Florida'}, 'officialTitle': 'Measurement of Natriuretic Hormone Peptides in Exacerbation of Asthma', 'orgStudyIdInfo': {'id': 'acute asthma'}}, 'contactsLocationsModule': {'locations': [{'zip': '33613', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Usf Asthma Allergy and Immunology Cru', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of South Florida', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prinicpal investigator', 'investigatorFullName': 'Richard Lockey', 'investigatorAffiliation': 'University of South Florida'}}}}