EXACO - Cohort of Patients with Chronic Obstructive Pulmonary Disease 
Responsable(s) :
Masure Frédéric
Cortot Alexis
Schuck Stephane
Cortot Alexis
Schuck Stephane
Date de modification : 01/01/2020 | Version : 1 | ID : 73257
| Général | |
| Identification | |
| Nom détaillé | Cohort of Patients with Chronic Obstructive Pulmonary Disease |
| Sigle ou acronyme | EXACO |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | CNIL |
| Thématiques générales | |
| Domaine médical |
Pneumology |
| Pathologie, précisions | Chronic obstructive pulmonary disease |
| Déterminants de santé |
Others (specify) |
| Mots-clés | bronchitis, COPD, exacerbation, cohort |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Masure |
| Prénom | Frédéric |
| fredmasure@gmail.com | |
| Organisme | Saint Remi Medical Group |
| Nom du responsable | Cortot |
| Prénom | Alexis |
| alexis-cortot@chru-lille.fr | |
| Organisme | Lille Regional University Hospital |
| Nom du responsable | Schuck |
| Prénom | Stephane |
| stephane.schuck@kappasante.com | |
| Organisme | Kappa Santé |
| Collaborations | |
| Financements | |
| Financements |
Private |
| Précisions | AltanaPharma, Astra-Zeneca, Boehringer-Ingelheim, GlaxoSmithKline, Pfizer |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | Société de Pneumologie de Langue Française |
| Statut de l’organisation |
Secteur Public |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Cohort study |
| Origine du recrutement des participants |
A selection of health care professionals |
| Informations complémentaires concernant la constitution de l'échantillon | 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. |
| Objectif de la base de données | |
| Objectif principal |
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. |
| Critères d'inclusion |
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. |
| Type de population | |
| Age |
Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population concernée |
Sick population |
| Sexe |
Male Woman |
| Champ géographique |
National |
| Détail du champ géographique | France |
| Collecte | |
| Dates | |
| Année du premier recueil | 2006 |
| Année du dernier recueil | 2010 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
[1000-10 000[ individuals |
| Détail du nombre d'individus | 835 |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Clinical data Declarative data |
| Données cliniques, précisions |
Direct physical measures Medical registration |
| Détail des données cliniques recueillies | 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. |
| Données déclaratives, précisions |
Paper self-questionnaire Phone interview |
| Détail des données déclaratives recueillies | Self-monitoring log (each occurrence of unusual respiratory distress for 2 days or more). |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Health event/morbidity Quality of life/health perception |
| Modalités | |
| Mode de recueil des données | Collected by hospital and/or private respiratory physicians. |
| Suivi des participants |
Yes |
| Détail du suivi | 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). |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Lien vers le document | http://www.em-consulte.com/rmr/article/134729 |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) | To be decided. |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
