NCT04038268

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

1.1 years

First QC Date

July 12, 2019

Last Update Submit

December 28, 2020

Conditions

Keywords

ImmunotherapyReal Clinical PracticeRespiratory diseaseAeroallergensIgE-dependent hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • Patients who refuse to give their informed consent
  • Food immunotherapy
  • Venom Immunotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Pascal Demoly

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2019

First Posted

July 30, 2019

Study Start

September 1, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

December 29, 2020

Record last verified: 2020-12

Locations