- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04038268
Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice (CHOICE)
Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice: an International E-survey
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.
Objective: 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).
During 12 months:
- 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).
- 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).
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Montpellier, Frankrig, 34295
- Uhmontpellier
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion criteria:
- Patients with IgE mediated respiratory allergy
- Patients who will initiate any type of aeroallergen AIT according to real life clinical standards of practice
- Any type of aeroallergen for AIT will be included : pollen, house dust mite, animal, dander, moulds
- Patient who is under the care of the Doctor participating in the survey
Exclusion criteria:
- Patients who refuse to give their informed consent
- Food immunotherapy
- Venom Immunotherapy
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Patients
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
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Prescribers
Doctors who are currently prescribing AIT as part of their regular clinical practice
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Clinical criteria in AIT
Tidsramme: 1 day
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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". caused by an IgE-dependent-hypersensitivity to aeroallergens Among the different criteria selected by participants, order of priority of AIT drivers will be established |
1 day
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Pascal Demoly, University Hospital, Montpellier
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- RECHMPL19_0361
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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