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).

Study Overview

• Status: Completed
• Conditions: Allergen Immunotherapy

• Study Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical criteria in AIT	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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Pascal Demoly, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: July 12, 2019
• First Submitted That Met QC Criteria: July 26, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Immunotherapy; Respiratory disease; Real Clinical Practice; Aeroallergens; IgE-dependent hypersensitivity
• Other Study ID Numbers: RECHMPL19_0361

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No