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CHOICE: Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT04038268
Collaborator
(none)
400
Enrollment
1
Location
13
Actual Duration (Months)
30.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Criteria Used by Health Professionals on the Selection of Allergen Immunotherapy in Real Clinical Practice: an International E-survey
    Actual Study Start Date :
    Sep 1, 2019
    Actual Primary Completion Date :
    Sep 30, 2020
    Actual Study Completion Date :
    Sep 30, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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
    Prescribers

    Doctors who are currently prescribing AIT as part of their regular clinical practice

    Outcome Measures

    Primary Outcome Measures

    1. Clinical criteria in AIT [1 day]

      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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: Pascal Demoly, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT04038268
    Other Study ID Numbers:
    • RECHMPL19_0361
    First Posted:
    Jul 30, 2019
    Last Update Posted:
    Dec 29, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Immunotherapy
    Real Clinical Practice
    Respiratory disease
    Aeroallergens
    IgE-dependent hypersensitivity

    Study Results

    No Results Posted as of Dec 29, 2020