EVORA - Evaluation of Oralair® in real conditions of use

Head :
BLIN Patrick, Universite de Bordeaux - Plateforme Bordeaux PharmacoEpi - Service de pharmacologie médicale - CIC Bordeaux CIC1401
MOLIMARD Mathieu, Universite de Bordeaux - Plateforme Bordeaux PharmacoEpi - Service de pharmacologie médicale - CIC Bordeaux CIC1401

Last update : 10/27/2017 | Version : 1 | ID : 73297

print
Print
xml
XML

Export to XML

Please choose the format :

pdf
PDF
xml
CSV (Excel)

Export to CSV

What sections do you want to export ?

Métadonnées
Identification
General Aspects
Collaborations
Funding
Governance of the database
Scientific investigator(s) (Contact)
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
Select all | Invert selection | No selection

Which version do you want to export ?

send
Send
General
Identification
Detailed name Evaluation of Oralair® in real conditions of use
Sign or acronym EVORA
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation CCTIRS n°14.514 - CNIL n°914403
General Aspects
Medical area General practice
Otolaryngology or ENT
Pediatrics
Pneumology
Study of allergies
Pathology (details) Allergic rhinitis with or without conjunctivitis with grass pollen
Health determinants Lifestyle and behavior
Medicine
Keywords Bordeaux PharmacoEpi Platform, Grass pollen, Adults and children, Prospective cohort, Allergic rhinitis with or without conjunctivitis, Oralair, Department of Medical Pharmacology
Collaborations
Funding
Funding status Private
Details LABORATOIRE STALLERGENES
Governance of the database
Sponsor(s) or organisation(s) responsible Universite de Bordeaux - Plateforme Bordeaux PharmacoEpi - Service de pharmacologie médicale - CIC Bordeaux CIC1401
Organisation status Public
Presence of scientific or steering committees Yes
Labelling and database evaluation Quality control of the data entered (internal control)
Scientific investigator(s) (Contact)
Name of the director BLIN
Surname Patrick
Address 146 rue Léo Saignat - Case 3641
33076 BORDEAUX Cedex
Phone 0557574675
Email patrick.blin@u-bordeaux.fr
Unit Universite de Bordeaux - Plateforme Bordeaux PharmacoEpi - Service de pharmacologie médicale - CIC Bordeaux CIC1401
Organization Université de Bordeaux
Name of the director MOLIMARD
Surname Mathieu
Address 146 rue Léo Saignat - Case 36
33076 BORDEAUX Cedex
Phone 0557571560
Email mathieu.molimard@u-bordeaux.fr
Unit Universite de Bordeaux - Plateforme Bordeaux PharmacoEpi - Service de pharmacologie médicale - CIC Bordeaux CIC1401
Organization Université de Bordeaux
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary An administrative base or a register
Base or register (detail) List of health-care professionals qualified in allergology via CEGEDIM
Database recruitment is is made on the basis of: Medication(s) taken
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Patients (adults and children from 5 years of age) were prospectively included between November 2014 and February 2015 by participating physicians specialising in allergology.
Database objective
Main objective Describe the prescription details of Oralair®: indication, dosage, date of introduction of the treatment with respect to the pollen season, concomitant treatments, in particular antihistamines, local corticosteroids, cromones and decongestants.
Inclusion criteria Patient initiating a treatment with Oralair® for the next pollen season,
Patient not previously treated with Oralair®.

Exclusion criteria:
Refusal to participate,
Patient not living in the area or expected to move during the study period,
Patient with a language barrier (unable to read the newsletter or complete self-questionnaires)
Patient participating in a therapeutic clinical trial
Population type
Age Childhood (6 to 13 years)
Adolescence (13 to 18 years)
Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Great age (80 years and more)
Population covered Sick population
Pathology X - Diseases of the respiratory system
Gender Male
Woman
Geography area National
Detail of the geography area Physicians in either private and hospital practice or both with an allergology activity in France
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 2014
Date of last collection (YYYY or MM/YYYY) 2015
Size of the database
Size of the database (number of individuals) [500-1000[ individuals
Details of the number of individuals 525 patients (311 adults and 214 children)
Data
Database activity Data collection completed
Type of data collected Clinical data
Declarative data
Biological data
Administrative data
Clinical data (detail) Direct physical measures
Details of collected clinical data General characteristics of the patient (sex, age, comorbidities, treatments) - Results of assays/tests and symptomatology of allergic rhinitis
Declarative data (detail) Paper self-questionnaire
Phone interview
Details of collected declarative data Collection of the perception of the symptoms of allergic rhinitis on quality of life before and after use of the treatment
Biological data (detail) Specific IgE assay results for grass pollen
Administrative data (detail) Surname, first name, phone number and e-mail address
Presence of a biobank No
Health parameters studied Health event/morbidity
Health care consumption and services
Quality of life/health perception
Care consumption (detail) Medical/paramedical consultation
Medicines consumption
Quality of life/perceived health (detail) Treatment outcome score (positive or negative benefit) from self-evaluation questionnaires of the symptoms on quality-of-life completed by patients
Procedures
Data collection method The study data is collected through standardised paper questionnaires completed by participating physicians and standardised self-questionnaires completed by patients. The data is then entered into a specific study database
Participant monitoring Yes
Monitoring procedures Monitoring by contact with the participant (mail, e-mail, telephone etc.)
Monitoring by contact with the referring doctor
Details on monitoring of participants After the inclusion consultation, participating physicians were asked to complete an end-of-study questionnaire at the end of the pollen season (by September 2015) for each patient included and monitored. For patients not seen by physicians, the questionnaire was completed directly with the patient during a telephone interview conducted by the clinical research associates of the coordinating Centre.
Links to administrative sources Yes
Linked administrative sources (detail) The population included and monitored in the study was compared with the EGB population
Promotion and access
Promotion
Access
Presence of document that lists variables and coding procedures Yes
Terms of data access (charter for data provision, format of data, availability delay) Ownership of and access to the study data were the subject of an agreement between the Université de Bordeaux and the laboratory. The terms of access to the database must be established by a request to the study’s scientific advisory board.
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

Partners - FAQ - Contact - Site map - Legal notices - Administration - Updated on August 21 2018 - Version 4.06.03

View Edit Create here