ITMO public health
Last update : 04/29/2015 | Version : 4 | ID : 188
| General | |
| Identification | |
| Detailed name | Descriptive pharmaco-epidemiological study on the use of Symbicort® Turbuhaler® in the treatment of asthma in France and impact of a new treatment strategy on compliance and asthma control |
| Sign or acronym | SYMBIOSE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 908418 - 28/01/2009 |
| General Aspects | |
| Medical area |
General practice Pneumology |
| Keywords | Symbicort® Turbuhaler®, cohort |
| Scientific investigator(s) (Contact) | |
| Name of the director | Piedbois |
| Surname | Pascal |
| Address |
3, rue de la Porte de l’hôpital 67065 Strasbourg Cedex, France |
| Phone | +33-388252401 |
| ppiedbois@strasbourg.unicancer.fr | |
| Organization | Centre Paul Strauss |
| Name of the director | Thomas-Delecourt |
| Surname | Florence |
| Phone | +33 (0)1 41 29 40 25 |
| florence.thomas@astrazenzca.com | |
| Unit | AstraZeneca |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | AstraZeneca |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | ASTRAZENECA |
| 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 institutions and services |
| 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. | The physicians and the pulmonologists participating in the study recruit the subjects to be included among the patients that they see in consultation and according to the inclusion criteria |
| Database objective | |
| Main objective |
Describe the characteristics of asthmatic patients treated with Symbicort Turbuhaler
Compare the characteristics of patients treated according to the therapeutic strategy Evaluate the level of asthma control and compliance with treatment of patients treated with Symbicort Turbuhaler |
| Inclusion criteria | Patients diagnosed as asthmatic by the physician and treated for this pathology with Symbicort Turbuhaler |
| 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 |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2009 |
| Date of last collection (YYYY or MM/YYYY) | 2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1844 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Medical registration |
| Declarative data (detail) |
Phone interview |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Quality of life/health perception |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration of 12 months |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Methods for accessing the database are currently being defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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