Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-27 @ 10:59 PM
Study NCT ID:
NCT04628260
Status:
COMPLETED
Last Update Posted:
2023-10-19
First Post:
2020-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UNCOVER - a Non-interventional Study to Investigate Undiagnosed Severe 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': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-18', 'studyFirstSubmitDate': '2020-11-06', 'studyFirstSubmitQcDate': '2020-11-11', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Primary objective is the Investigation of the prevalence of difficult-to-treat and severe Asthma eligible for Treatment with biologics.', 'timeFrame': '18 months', 'description': 'Number of patients with diagnosis of severe Asthma according to the ATS/ERS Definition of severe Asthma and number of severe Asthma patients eligible for one or more biologic Treatments for Asthma.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'UNCOVER is a non-interventional study to investigate the prevalence of difficult-to-treat and severe Asthma eligible for treatment with biologics in a cohort of patients with suspected, so far undiagnosed severe Asthma which were previously treated by General practitioners and Office-based pulmonologists.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Female and male patients are eligible for this non-interventional study when fulfilling all criteria for inclusion and None of the criteria for exclusion. 400 patients will be enrolled.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older at inclusion\n* written informed consent\n* currently diagnosed with Asthma fulfilling at least one of the criteria of potential severe Asthma\n* willing and able to complete the study questionnaire miniAQLQ\n\nExclusion Criteria:\n\n* biological Treatment for Asthma during the past 12 months\n* participation in a clinical Trial within the last 3 months\n* patients who are not able to read or write, who do not understand the nature of the study or the ICF or who are dependent from the investigator'}, 'identificationModule': {'nctId': 'NCT04628260', 'briefTitle': 'UNCOVER - a Non-interventional Study to Investigate Undiagnosed Severe Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Karl Landsteiner Institute for Clinical and Experimental Pneumology'}, 'officialTitle': 'UNCOVER - a Non-interventional Study to Investigate Undiagnosed Severe Asthma', 'orgStudyIdInfo': {'id': '213799'}}, 'contactsLocationsModule': {'locations': [{'zip': '1130', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Karl Landsteiner Institute for Clinical and Experimental Pneumology, Klinik Hietzing', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Wolfgang Pohl, Univ. Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Head of Karl Landsteiner Institut for Clinical and Experimental Pneumology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karl Landsteiner Institute for Clinical and Experimental Pneumology', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universitätsklinik für Innere Medizin II, Pulmologie', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}