EXACO - Cohort of Patients with Chronic Obstructive Pulmonary Disease 
Head :
Masure Frédéric
Cortot Alexis
Schuck Stephane
Cortot Alexis
Schuck Stephane
Last update : 01/01/2020 | Version : 1 | ID : 73257
| General | |
| Identification | |
| Detailed name | Cohort of Patients with Chronic Obstructive Pulmonary Disease |
| Sign or acronym | EXACO |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Pneumology |
| Pathology (details) | Chronic obstructive pulmonary disease |
| Health determinants |
Others (specify) |
| Keywords | bronchitis, COPD, exacerbation, cohort |
| Scientific investigator(s) (Contact) | |
| Name of the director | Masure |
| Surname | Frédéric |
| fredmasure@gmail.com | |
| Organization | Saint Remi Medical Group |
| Name of the director | Cortot |
| Surname | Alexis |
| alexis-cortot@chru-lille.fr | |
| Organization | Lille Regional University Hospital |
| Name of the director | Schuck |
| Surname | Stephane |
| stephane.schuck@kappasante.com | |
| Organization | Kappa Santé |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | AltanaPharma, Astra-Zeneca, Boehringer-Ingelheim, GlaxoSmithKline, Pfizer |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Société de Pneumologie de Langue Française |
| 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 care professionals |
| Additional information regarding sample selection. | One hundred and fifty investigating respiratory physicians forming a representative national sample of the profession, each including an average of 8 patients that meet the inclusion criteria. |
| Database objective | |
| Main objective |
The main aims of the study are to qualitatively and quantitatively describe the exacerbations in a cohort of COPD patients at different levels of severity and to confirm the existence of a sub-group of patients defined as frequent exacerbators who experience a high number of exacerbations over time.
Where applicable, to determine the threshold value (number of exacerbations) that distinguishes frequent exacerbations by assuming that 3 exacerbations per year, regardless of severity, are sufficient to class the patient as a “frequent” exacerbator. Several secondary aims will also be pursued. To identify factors associated with frequent exacerbators. To identify criteria more readily associated with exacerbation severity. To confirm the link between frequent exacerbators/accelerated decline in lung function. A validation of the VSRQ scale will be performed with the following metrics: replication; clinical validity through comparison with the St. George questionnaire; VSRQ unidimensional structure; VSRQ internal consistency; sensitivity to change; minimal important distance. |
| Inclusion criteria |
Respiratory physicians (private practice or hospital: CHG, CHU) will enrol patients aged 40 and over with stage II or III COPD according to SPLF criteria (2003); smokers or ex-smokers (>15 pack-years); stable and with post-bronchodilator FEV1 lower than or equal to 80% of predicted value and FEV1/VC relationship <70%. Patients must accept and complete the self-monitoring log on a monthly basis and, at each exacerbation, can be contacted by phone every three months for 4 years. Participants shall sign a consent form.
The following may not be included: patients with active tuberculosis, cancer (or who received cancer treatment in the last 3 years), diffuse bronchiectasis, cystic fibrosis, asthma (in clinical history), or any other diagnosed lung diseases (sarcoidosis, pulmonary fibrosis, pneumoconiosis, etc.). Other non-inclusion criteria include exacerbation one month prior to enrolment; absence of a telephone and participation in another clinical or epidemiological study. |
| Population type | |
| Age |
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 | France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2006 |
| Date of last collection (YYYY or MM/YYYY) | 2010 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 835 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Socio-demographic characteristics; clinical profile and ongoing treatment; breathlessness scales (MRC/Borg Score), Pulmonary Function testing (PFT); 6-minute walking test (TM6); impact on daily life; quality of life (VSRQ self-administered questionnaire). Optional tests are: blood oxygen saturation; sputum cytology examination (SCE); signs of emphysema on computed tomography (CT); measurement of blood gas levels. Body Mass Index; breathlessness measured with MRC scale and 6-minute walking test. During each follow-up visit; onset of exacerbation episodes as well as any changes occurring since the last visit will be made known. |
| Declarative data (detail) |
Paper self-questionnaire Phone interview |
| Details of collected declarative data | Self-monitoring log (each occurrence of unusual respiratory distress for 2 days or more). |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Quality of life/health perception |
| Procedures | |
| Data collection method | Collected by hospital and/or private respiratory physicians. |
| Participant monitoring |
Yes |
| Details on monitoring of participants | 4-year follow-up following enrolment. Once a year, the results of a full pulmonary function test; 6-minute walking test and MRC breathlessness scale score will be gathered; the quality of life questionnaire and Borg Scale score will also be completed once a year. Tests will not be mandatory but carried out as part of the treatment course and regular follow-up of patients with COPD. The patient will complete the self-monitoring log when there is unusual respiratory distress for 2 days or more. He/she will also include his/her monthly respiratory progress in the log at the end of each follow-up month. A quarterly telephone interview where the telephone operator will ensure that all exacerbations were recorded in the log. Otherwise, data will be specified. This interview will minimise the risk of good response bias (the most suitable patients will better complete the questionnaire). |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.em-consulte.com/rmr/article/134729 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | To be decided. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
