Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-28 @ 4:21 AM
Study NCT ID:
NCT04038268
Status:
COMPLETED
Last Update Posted:
2020-12-29
First Post:
2019-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012120', 'term': 'Respiration Disorders'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-28', 'studyFirstSubmitDate': '2019-07-12', 'studyFirstSubmitQcDate': '2019-07-26', 'lastUpdatePostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical criteria in AIT', 'timeFrame': '1 day', 'description': 'Clinical criteria used by treating clinicians and by the patients themselves, when establishing AIT as treatment in a patient with respiratory disease. These are called "drivers of prescription".\n\ncaused by an IgE-dependent-hypersensitivity to aeroallergens Among the different criteria selected by participants, order of priority of AIT drivers will be established'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunotherapy', 'Real Clinical Practice', 'Respiratory disease', 'Aeroallergens', 'IgE-dependent hypersensitivity'], 'conditions': ['Allergen Immunotherapy']}, 'descriptionModule': {'briefSummary': "Background : Allergen Immunotherapy (AIT) is the only etiological treatment for allergic respiratory diseases. In order to improve the competence on the use of AIT, it is important to extend the investigator's knowledge on its use in routine clinical practice, outside the experimental setting of clinical trials, in real life population of patients receiving AIT.\n\nObjective: To evaluate the clinical criteria used by treating clinicians and by the patients themselves, when establishing AIT as treatment in a patient with respiratory disease caused by an IgE-dependent-hypersensitivity to aeroallergens Methods: In 6 country (Denmark, France, Germany, Norway, Spain \\& Sweden), the national coordinator will be directly responsible for selection of Survey Doctor's participants (Investigators).\n\nDuring 12 months:\n\n* Firstly, each investigator will complete the Survey Doctor, online, on SurveyMonkey platform to explain what are the key drivers in Allergen Immunotherapy (AIT) selection (Doctors' Questionnaire, DQ).\n* On the other hand, at each AIT prescription to a patient, doctors will complete the Survey Patient, on the same platform, to explain how and why they have chosen this type of AIT (Patients' Questionnaire, PQ)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with IgE mediated hypersensitivity to aeroallergens who will initiate AIT, either SCIT, SLIT-drops or SLIT-tablets according to real life clinical standards of practice', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Patients with IgE mediated respiratory allergy\n* Patients who will initiate any type of aeroallergen AIT according to real life clinical standards of practice\n* Any type of aeroallergen for AIT will be included : pollen, house dust mite, animal, dander, moulds\n* Patient who is under the care of the Doctor participating in the survey\n\nExclusion criteria:\n\n* Patients who refuse to give their informed consent\n* Food immunotherapy\n* Venom Immunotherapy'}, 'identificationModule': {'nctId': 'NCT04038268', 'acronym': 'CHOICE', 'briefTitle': 'Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice: an International E-survey', 'orgStudyIdInfo': {'id': 'RECHMPL19_0361'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': 'Adults and children, males and females, with IgE mediated pollen, house dust mites, animal dander and moulds respiratory allergy who will initiate aeroallergen AIT, either SCIT, SLIT-drops or SLIT-tablets according to real life clinical standards of practice'}, {'label': 'Prescribers', 'description': 'Doctors who are currently prescribing AIT as part of their regular clinical practice'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Pascal Demoly', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}