Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-01-24 @ 8:04 AM
Study NCT ID:
NCT01741805
Status:
WITHDRAWN
Last Update Posted:
2016-07-29
First Post:
2012-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa
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0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Slow recruitment of patients', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2014-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-28', 'studyFirstSubmitDate': '2012-12-02', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2016-07-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Expiratory Volume in 1 second (FEV1)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Carbon Monoxide Diffusion Capacity (DLCO)', 'timeFrame': '1 year'}, {'measure': 'Percent eosinophils in induced sputum sample', 'timeFrame': '1 year'}, {'measure': 'Bronchiectasis on computerized tomography (CT)', 'timeFrame': '1 year)'}, {'measure': 'Blood level of Total immunoglobulin E (IgE)', 'timeFrame': '1 year'}, {'measure': 'Presence of blood antibody to Aspergillus Fumigatus', 'timeFrame': '1 year'}, {'measure': 'Fraction of Nitric Oxide (NO) in expired air', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Asthma is a chronic illness characterized by inflammation of the airways. Severe asthma is defined in the literature as asthma not controlled by medication. In recent years it has become known that severe asthma is a variable disease and has subtypes relating to the age of onset, type of inflammation and allergy, obesity, etc.\n\nOur aim is to characterize the phenotypes of severe asthma population in our clinic and compare the prevalent phenotypes to the phenotypes described before.', 'detailedDescription': 'Study measures will include the following:\n\n* asthma demographic and symptoms questionnaire\n* Validation of proper inhaler technique\n* Height, weight measurements\n* Forced spirometry and reversibility testing\n* DLCO\n* Fractional excretion of NO in exhaled breath\n* Chest and sinus CT\n* Induced sputum analysis\n* Complete blood count, electrolytes, immunoglobulin E, Aspergillus Specific IgE\n* Skin allergy testing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population of petients with severe asthma, described by presence of symptoms despite adequate treatment as described in the following sections.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Presence of Asthma- typical symptoms and signs accompanied by either: a. obstruction in Spirometry, OR- b. positive methacholine test\n2. Regular use of high dose of inhaled corticosteroids (1000 micrograms of fluticasone per day or equivalent) in addition to a long acting beta agonist (LABA).\n3. Lack of asthma control- 2 or more exacerbations in the past year- exacerbations defined by hospitalization or care in an emergency department or treatment with systemic glucocorticosteroids for exacerbation of asthma symptoms.\n\nExclusion Criteria:\n\n1. Presence of another relevant respiratory illness, such as chronic obstructive pulmonary disease (COPD)\n2. lack of adherence to medical therapy'}, 'identificationModule': {'nctId': 'NCT01741805', 'briefTitle': 'The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'The Clinical and Laboratory Phenotypes of Severe Asthma Patients in Clalit Health Services Haifa.', 'orgStudyIdInfo': {'id': 'CMC-12-0032-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Severe Asthma', 'description': 'Patients with severe asthma as specified under inclusion, exclusion criteria', 'interventionNames': ['Other: Severe Asthma']}], 'interventions': [{'name': 'Severe Asthma', 'type': 'OTHER', 'description': 'Demographic data, Spirometry, induced sputum, IgE, Aspergillus specific IgE', 'armGroupLabels': ['Severe Asthma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34632', 'city': 'Haifa', 'country': 'Israel', 'facility': 'Pulmonology Institute, Carmel Medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'overallOfficials': [{'name': 'Michal Shteinberg, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pulmonology Institute, Carmel Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}