Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-03-03 @ 2:29 AM
Study NCT ID:
NCT00594750
Status:
SUSPENDED
Last Update Posted:
2025-11-21
First Post:
2008-01-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mechanisms of 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_WITHOUT_DNA', 'description': 'Sputum, whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}}, 'statusModule': {'whyStopped': 'The restrictions on research imposed for the COVID-19 pandemic prevented us from continuing recruitment and visits. At this stage our funding is not sufficient to continue enrollment so we will put the study in a hold pattern.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2006-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2008-01-02', 'studyFirstSubmitQcDate': '2008-01-15', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rheological measurements (viscosity and elasticity) in sputum from patients with acute severe asthma', 'timeFrame': '1-2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://acrc.ucsf.edu', 'label': 'UCSF Airway Clinical Research Center website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to identify the causes of asthma that were not previously suspected, to better understand the effects of inhaled steroids on asthma and to identify new way to treat asthma.', 'detailedDescription': 'In this study, we will explore mechanisms of exacerbation in asthma by careful characterization studies in asthmatics presenting in acute severe exacerbation. Specifically, we will determine the frequency of secretor status in these subjects by blood and saliva testing, and we will also perform a detailed cellular and biochemical analysis of their airway secretions. We will collect airway secretions using two methods. One method will be to have subjects cough sputum into a clean plastic container. The other method only applies to asthmatics with near-fatal asthma requiring intubation and mechanical ventilation. In these asthmatics, we will collect airway secretions by tracheal aspirate using methods normally applied in their clinical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'emergency deparment, admitted patients in the ICU and inpatient wards', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female subjects with a history of asthma between the ages of 18 to 75 years.\n2. Physician diagnosis of asthma.\n3. Currently experiencing an acute exacerbation of asthma. This exacerbation may be severe necessitating treatment in the emergency room, ICU, or hospital ward.\n4. Ability to provide informed consent.\n\nExclusion Criteria:\n\n1. Lung disease other than asthma.\n2. Females who are lactating or who are pregnant.\n3. Use of recreational drugs in the 1 month preceding the study.'}, 'identificationModule': {'nctId': 'NCT00594750', 'acronym': 'MECA', 'briefTitle': 'Mechanisms of Exacerbation of Asthma', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Mechanisms of Exacerbation of Asthma', 'orgStudyIdInfo': {'id': '10-01329'}, 'secondaryIdInfos': [{'id': '5R01HL080414-08', 'link': 'https://reporter.nih.gov/quickSearch/5R01HL080414-08', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Asthma', 'description': 'People who have been diagnosed with Asthma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Airway Clinical Research Center', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'John V Fahy, M.D., M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}