ITMO public health
Last update : 02/04/2016 | Version : 2 | ID : 60115
| General | |
| Identification | |
| Detailed name | Asthma and Airway Obstruction Cohort: Clinicobiological Cohort Follow-up |
| Sign or acronym | COBRA |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL : 28/01/2008 |
| General Aspects | |
| Medical area |
Pneumology |
| Health determinants |
Climate Pollution |
| Keywords | Health episodes, severity |
| Scientific investigator(s) (Contact) | |
| Name of the director | Aubier |
| Surname | Michel |
| Address | Hôpital Bichat, 46 rue Henri Huchard 75018 PARIS |
| Phone | +33 (0)1 40 25 68 00 |
| michel.aubier@bch.aphp.fr | |
| Unit | Université Paris 7, APHP, Inserm U 700 |
| Organization | INSERM |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Inserm, CHU de Nîmes, LEGS POIX, GSK, AstraZeneka, Chiesi |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Institut National de la Santé et de la Recherche Médicale |
| Organisation status |
Public |
| 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 |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective Closing date for inclusion: end of 2014 Other bodies active in creating this cohort: CHU, CHG |
| Database objective | |
| Main objective | General objective: to establish a biological resource centre (serum, DNA) for two cohorts of patients with asthma and COBP monitored over a 10 year period. Secondary objective: to discover biological markers of severity (using proteomics technology) and genetic risk factors (by genomic-based approaches) associated with the evolution of these pathologies. |
| Inclusion criteria | Two cohorts: one with asthmatics and one with individuals affected by COBP; subjects included between the ages of 18 and 80 years old. Asthma cohort: including patients who are non-smokers and smokers with compatible clinical history and individuals with a reversible obstructive airway disease, based on a FEV1/CV <75% and an FEV1 baseline value improvement of 12% or 200 ml after inhalation of 400 µg of Salbutamol. COBP cohort: including patients who are smokers (>10 packets per year) presenting with an obstructive airway disease (FEV1/CV <75%) and an FEV1 improvement of less than 10% after inhalation of 200 µg of Salbutamol. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Multicentric cohort throughout France (15 centres) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 03/2008 |
| Date of last collection (YYYY or MM/YYYY) | 03/2018 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | - 1000 asthmatiques - 500 BPCO |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | <Clinic: relevant personal and familial medical history (Asthma cohort: eczema, asthma, rhinoconjunctivitis; COPD cohort: asthma, chronic bronchitis, emphysema, respiratory insufficiency), complete physical examination. Therapeutic: concomitant medication. Quality of life: patient is to be questioned regarding quality of life with a validated Juniper questionnaire (Asthma cohort) |
| Declarative data (detail) |
Paper self-questionnaire |
| Details of collected declarative data | Demographic: initials, date of birth, sex, geographic origin, professional activity. Risk factors: smoking |
| Paraclinical data (detail) | Imaging: chest x-ray, CT scan for COBP EFR, allergy tests, bronchial fibroscopy for a sub-group of patients (2 centres). |
| Biological data (detail) | Type of samples taken: Blood and serum |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum DNA |
| Details of biobank content | Serum bank, DNA bank |
| Health parameters studied |
Health event/morbidity Health event/mortality Quality of life/health perception |
| Quality of life/perceived health (detail) | Quality of life: patient is to be questioned regarding quality of life with a validated Juniper questionnaire (Asthma cohort) |
| Procedures | |
| Data collection method | Self-administered questionnaire: manual input Interview: manual input Clinical examinations: manual input Biological analysis: manual input |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Duration of follow-up per patient: individuals are monitored over a period of ten years after selection, with one visit every six months during the first five years, followed by every year for the next five years. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | Cobra.pdf |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams Contractual access subject to COBRA Scientific Council validation. Research projects that can use clinical and/or biological cohort data are encouraged and validated by the Scientific Council (2 members per centre). Data may not be used by industrial teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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