Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT01397760
Status:
UNKNOWN
Last Update Posted:
2011-07-20
First Post:
2011-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-19', 'studyFirstSubmitDate': '2011-07-12', 'studyFirstSubmitQcDate': '2011-07-19', 'lastUpdatePostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of asthma hospitalization', 'timeFrame': 'ONE YEAR Of Omalizumab USE'}], 'secondaryOutcomes': [{'measure': 'Decrease the doses of oral steroids', 'timeFrame': 'ONE YEAR Of Omalizumab USE'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['DIFFICULT TO CONTROL ASTHMA', 'OMALIZUMABE'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is do describe the experience in the use of omalizumabe, in a real life scenario, in uncontrolled severe asthmatic patients attended in specialist outpatient clinics, and its efficacy and safety. The efficacy of omalizumab in the population observed will be evaluated as reduction of uncontrolled asthma related events, i.e. exacerbations, emergency dept. visits, hospitalization and asthma-related treatment (decrease of asthma medication).', 'detailedDescription': 'Omalizumab is indicated in children over 6 years of age, with diagnosis of difficult to control asthma, presenting a component of atopy demonstrated preferably positive skin tests (prick test) or in vitro reactivity (rast) allergens common inhalants. Patients must also present the total serum IgE levels between 30 and 700UI/mL. Children until 12 years the IgE level is between 30 and 300 IU/ml.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '20 PATIENTS WITH difficult to treat asthma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients on optimal asthma treatment, good compliance and no response to treatment according to asthma consensus (GINA/NAEEP and the Latinamerican Consensus for Difficult to treat Asthma)'}, 'identificationModule': {'nctId': 'NCT01397760', 'briefTitle': 'Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma', 'organization': {'class': 'INDIV', 'fullName': 'Fiks, Iara Nely, M.D.'}, 'officialTitle': 'Retrospective Study for Description of The Use Of Omalizumab In Patients With Difficult To Control Asthma', 'orgStudyIdInfo': {'id': 'iara fiks 1'}}, 'contactsLocationsModule': {'locations': [{'zip': '04508011', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'IARA N FIKS, MD', 'role': 'CONTACT', 'email': 'IFIKS@UOL.COM.BR', 'phone': '55 11 38453800'}], 'facility': 'Iara Nely Fiks', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'iara n fiks, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'pulmonary sao luiz hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fiks, Iara Nely, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'oldNameTitle': 'IARA NELY FIKS', 'oldOrganization': 'IARA NELY FIKS'}}}}