Component Resolved Diagnostics (CRD) and mHealth for Pollen Allergy In Southern Europe.

Allergic Rhinitis Clinical Trial

— IT-2020-MC  

Official title:

CRD and mHealth for Pollen Allergy in Southern Europe. A Multicenter Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636919
• Other study ID #: 2017-68
• Status: Completed
• Start date: January 29, 2018
• Est. completion date: July 12, 2023

Study information

• Verified date: July 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: July 12, 2023
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic
• Rhinitis, Allergic, Seasonal

Intervention

Other:
• e-BOOK
Patients will filled an e (carnet) included the questionnaire includes the Control of Allergic Rhinitis and Asthma Test (CARAT)

Locations

Country	Name	City	State
France	Assistance Publique Des Hopitaux de Marseille	Marseille	Paca

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adapted treatment	The number of patients who had recourse to the theoretical treatment of AIT	8 months