USB - Follow-up cohort of patients with chronic obstructive pulmonary disease treated by Seretide Diskus 500 µg / 50 doses ®
Head :
Pribil Céline, Laboratoire GSK
Last update : 07/22/2015 | Version : 2 | ID : 164
| General | |
| Identification | |
| Detailed name | Follow-up cohort of patients with chronic obstructive pulmonary disease treated by Seretide Diskus 500 µg / 50 doses ® |
| Sign or acronym | USB |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 907277 |
| General Aspects | |
| Medical area |
Pneumology |
| Keywords | cohort, Seretide Diskus |
| 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. | A sample of 360 investigating general doctor will be formed by sample random sampling using a validated sampling frame. A sample of 120 investigating pneumologists will be formed by simple random sampling using a validated sampling frame. The day of consultation, each doctor will keep a registry of patients treated for OCPD. The investigating doctors will ask, using a medical inclusion questionnaire, the first 2 to 3 patients from the registry, for whom they are initiating a treatment via SERETIDE Diskus 500 µg / 50 doses. |
| Database objective | |
| Main objective |
Describe the population pursuing SERETIDE Diskus 500 µg / 50 doses within the framework of treating OCPD, the methods for prescribing it and their actual conditions of use (observance in particular) as well as the clinical change in patients.
Evaluate the impact of the fixed-dose combinations on objective morbidity and on perceived morbidity of OCPD. |
| Inclusion criteria |
• Patient in whom a treatment via Seretide® Diskus 50 µg / 50 doses is initiated on the day of inclusion
• Patients over the age of 40 years, • Smokers or ex-smokers (> 15 pack-years) |
| Population type | |
| Age |
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) | 2007 |
| Date of last collection (YYYY or MM/YYYY) | 01/2011 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 767 |
| 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 event/morbidity Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Data collection method | • A doctor characteristics sheet completed at the location of the center• A non-inclusion registry of the patients treated for OPCD that consult during the inclusion period • An inclusion questionnaire completed by the doctor on D0 • A follow-up questionnaire completed by the doctor at each naturalistic follow-up visit throughout the entire duration of the study• A self-questionnaire completed by the patient at the inclusion visit • A self questionnaire completed by the patient at each naturalistic follow-up visit throughout the entire duration of the study• A questionnaire on the latest news for patients who left the study during follow-up |
| Participant monitoring |
Yes |
| Details on monitoring of participants | During follow-up, investigating doctors at 3, 6, 9 and 12 months (+/- 15 days) will question included patients using a medical follow-up questionnaire and will give them a self-questionnaire to be completed independent to the investigator doctor after each follow-up visit. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/Pubmed-USB |
| Description | List of publications in 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 |
