OCSIGEN - Follow-up cohort of asthmatic patient treated with inhaled corticosteroid 
Head :
Pribil Céline, Laboratoire GSK
Last update : 01/01/2019 | Version : 2 | ID : 165
| General | |
| Identification | |
| Detailed name | Follow-up cohort of asthmatic patient treated with inhaled corticosteroid |
| Sign or acronym | OCSIGEN |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Pneumology |
| Health determinants |
Medicine |
| Keywords | inhaled steroids, cohort |
| Scientific investigator(s) (Contact) | |
| Name of the director | Pribil |
| Surname | Céline |
| Phone | +33 (0)1 39 17 90 62 |
| celine.c.pribil@gsk.com | |
| Unit | Laboratoire GSK |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | GSK laboratory |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Laboratoire GSK |
| Organisation status |
Private |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Longitudinal study (except cohorts) |
| Database recruitment is carried out by an intermediary |
A selection of health care professionals |
| 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. |
GP section:
The investigating physicians will be the Thalès physicians accepting to participate in the study Pneumologist section: The investigating centers for the study will be obtained by random drawing stratified over the region. The minimum survey rate allowing for representation of each of the regions is about 4%, which corresponds to a sample of 101 pneumologists in France |
| Database objective | |
| Main objective | Describe the conditions of use of the fluticasone and other inhaled corticosteroids in a pragmatic situation in general practice and in specialized pneumology, evaluate the severity of the asthma of patients cared for and measure the adequacy of the care with the national recommendations |
| Inclusion criteria |
GP section:
The eligible population is defined by all of the asthmatic patients over the age of 15 years who have consulted at least twice in the previous year and in whom an inhaled corticotherapy is in progress (at least one prescription in the last six months). Patients defined as such who come to consult spontaneously for asthma during the period of inclusion will also be included. Refusal to participate and the association of the asthma with an OCPD are criteria for non-inclusion. Pneumologist section: Asthmatic persons cared for in liberal pneumology present in the practice of the investigators of the study and meeting the inclusion criteria |
| Population type | |
| Age |
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 |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2004 |
| Date of last collection (YYYY or MM/YYYY) | 2009 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1691 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | GP section:The characteristics of the patients will be collected in historical data present in the Thalès database, then at the inclusion visit and during all of the visits occurring during the follow-up period. At each visit, the stage of the severity of the patients according to GINA clinical and therapeutic classifications will be evaluatedDuring the inclusion period, at each consultation of an eligible patient, the study will be offered to him. Where applicable, the computerized inclusion questionnaire is filled out and the patient is included in the cohort. At each consultation carried out during the follow-up period, a ""pop-up"" screen containing the follow-up questionnaire will appear on the investigator's computer screen.Pneumologist section:The conditions for the use of inhaled steroids according to the stages of severity will be described through three questionnaires: a historical questionnaire (data coming from the medical dossier of the patient), an inclusion questionnaire and a follow-up questionnaire which will be implemented in computerized format. A fourth questionnaire, self-administered pertaining to the control of the asthma, will be completed by the patient at inclusion and at each visit during the follow-up. The collection of data will be carried out on a computerized support via a secure internet site devoted to the study. The physician will directly enter the information desired into the on-line forms |
| Participant monitoring |
Yes |
| Details on monitoring of participants | GP section:Follow-up for 24 months, Pneumologist section:Follow-up for 24 months, at each new consultation carried out during the follow-up period, the pneumologist fills out the computerized on-line follow-up questionnaire |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/pubmed-ocsigen |
| Description | Liste des publications dans Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Publications in progress |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
