Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-01-02 @ 4:42 AM
Study NCT ID:
NCT06916104
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-04-08
First Post:
2025-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Respiratory Allergy on Response to Initiation of Biotherapy in Severe Asthma in Adult Severe Asthmatic Patients Followed at Poitiers University Hospital on Biotherapy
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': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2025-03-31', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Find out whether a positive respiratory allergy test influences the efficacy of one or more biotherapies', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'analyze the allergological workup, particularly with regard to common pneumallergens', 'timeFrame': '1 year'}, {'measure': 'look at the response to the biotherapy used', 'timeFrame': '1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Severe Asthma', 'Biotherapy', 'Respiratory Allergy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to take stock of the situation of adult patients with severe asthma on biotherapy, followed up at Poitiers University Hospital, and in particular to increase our knowledge of factors predictive of response to biotherapy. The main aim is to improve the management of adult severe asthma patients treated with biotherapy, according to their allergic status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'severe asthma patients on dual therapy at POITIERS University Hospital', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Severe asthma patient on biotherapy\n* Age \\> or = 18 years\n* Follow-up at Poitiers University Hospital\n\nExclusion Criteria:\n\n* Absence of allergological assessment\n* Patient's refusal to participate in study"}, 'identificationModule': {'nctId': 'NCT06916104', 'acronym': 'IARBASP', 'briefTitle': 'Impact of Respiratory Allergy on Response to Initiation of Biotherapy in Severe Asthma in Adult Severe Asthmatic Patients Followed at Poitiers University Hospital on Biotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Poitiers University Hospital'}, 'officialTitle': 'Impact of Respiratory Allergy on Response to Initiation of Biotherapy in Severe Asthma in Adult Severe Asthmatic Patients Followed at Poitiers University Hospital on Biotherapy', 'orgStudyIdInfo': {'id': 'IARBASP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'adult patients with severe asthma on biotherapy', 'interventionNames': ['Other: search for respiratory allergies']}], 'interventions': [{'name': 'search for respiratory allergies', 'type': 'OTHER', 'description': 'analyses in terms of biotherapy and respiratory allergy', 'armGroupLabels': ['adult patients with severe asthma on biotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'Chu Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poitiers University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}