Component Resolved Diagnostics (CRD) and mHealth for Pollen Allergy In Southern Europe. (IT-2020-MC)

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Completed

Conditions

Allergic Rhinitis

Treatments

Other: e-BOOK

Study type

Observational

Funder types

Other

Identifiers

NCT03636919
2017-68

Details and patient eligibility

About

Pollen allergic rhinitis is a very common condition whose symptomatic treatment is not always sufficient or satisfactory. The indication for allergic immunotherapy (IT) therefore often arises. The indication is based on the interrogation of the patient (chronology and severity of symptoms) and skin tests. But the interrogation, necessarily retrospective, brings often vague information and skin tests can be positive for allergens that have no clinical role (cross allergies). The objective of the project is to help the clinician in the indication of the IT, on the one hand by setting up a prospective and computerized collection of symptoms by a computer logbook accessible by the mobile phone of the patient. on the other hand by performing on the patient's serum a molecular diagnosis allow the identification of the major allergens to which the patient is sensitized. The same study will be conducted in 7 centers in southern European countries in patients aged 10 to 60 years with pollinosis. The examinations added by the research will take place during two routine visits: during a first visit, these patients will answer a standardized questionnaire, have a battery of allergological skin tests and a blood sample for molecular diagnosis. An application will then be loaded on their mobile phone and they will record their symptoms and medication during the pollen season. During a second visit, at the end of the pollen season, the allergist, in view of the data collected in the electronic notebook and the results of the molecular diagnosis will be able to prescribe a possible IT.

Full description

Pollen allergic rhinitis is a very common condition whose symptomatic treatment is not always sufficient or satisfactory. The indication for allergic immunotherapy (IT) therefore often arises. The indication is based on the interrogation of the patient (chronology and severity of symptoms) and skin tests. But the interrogation, necessarily retrospective, brings often vague information and skin tests can be positive for allergens that have no clinical role (cross allergies). The objective of the project is to help the clinician in the indication of the IT, on the one hand by setting up a prospective and computerized collection of symptoms by a computer logbook accessible by the mobile phone of the patient. on the other hand by performing on the patient's serum a molecular diagnosis allow the identification of the major allergens to which the patient is sensitized. The same study will be conducted in 7 centers in southern European countries (where the diagnosis of pollen allergies is the most complex) in patients aged 10 to 60 years with pollinosis. The examinations added by the research will take place during two routine visits: during a first visit, these patients will answer a standardized questionnaire, have a battery of allergological skin tests and a blood sample for molecular diagnosis. An application will then be loaded on their mobile phone and they will record their symptoms and medication during the pollen season. During a second visit, at the end of the pollen season, the allergist, in view of the data collected in the electronic notebook and the results of the molecular diagnosis will be able to prescribe a possible IT.

Enrollment

900 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

over the age of 18, good French, possession of a SmartPhone, Android or i-Phone, signature of the consent form.

Exclusion criteria

Immunotherapy already performed, other severe chronic disease (eg dysimmunitary disease, immunodeficiency, chronic sinusitis and nasal polyposis), residence more than 30 km from the pollen sensor

Trial design

900 participants in 1 patient group

experimental group
Description:
patient with pollen allergic rhinitis patients will filled an e-BOOK included questionnaires of life
Treatment:
Other: e-BOOK

Trial contacts and locations

1

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Central trial contact

denis andre charpin, md

Data sourced from clinicaltrials.gov

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