CORINES - Identification of adrenal insufficiency and / or Cushing's syndrome in patients treated with inhaled corticosteroids 
Head :
Molimard Mathieu, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Moore Nicholas, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Moore Nicholas, Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen
Last update : 09/05/2017 | Version : 1 | ID : 2932
| General | |
| Identification | |
| Detailed name | Identification of adrenal insufficiency and / or Cushing's syndrome in patients treated with inhaled corticosteroids |
| Sign or acronym | CORINES |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Endocrinology and metabolism Pediatrics Pneumology |
| Health determinants |
Iatrogenic Medicine |
| Keywords | Adrenal insufficiency, Cushing's syndrome, inhaled corticosteroids, retrospective cohort, pharmacoepidemiology, Department of Pharmacology, Bordeaux |
| Scientific investigator(s) (Contact) | |
| Name of the director | Molimard |
| Surname | Mathieu |
| Address | Bât du Tondu - Case 41 - 146, Rue L2o Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| mathieu.molimard@pharmaco.u-boreaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Name of the director | Moore |
| Surname | Nicholas |
| Address | Bât du Tondu - Case 41 - 146, Rue L2o Saignat - 33076 BORDEAUX Cedex |
| Phone | + 33 (0)5 57 57 46 75 |
| nicholas.moore@pharmaco.u-boreaux2.fr | |
| Unit | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organization | Université Bordeaux |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | Laboratoires Merck and Co. (soutien inconditionnel) - Merck and Co. (unconditional support) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Service de Pharmacologie, CIC-P 0005-INSERM U657- Université Bordeaux Segalen |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Morbidity registers |
| Additional information regarding sample selection. | Patients were selected by pulmonologists, pediatricians, endocrinologists and emergency physicians in metropolitan France who agreed to participate. They were to identify all patients with adrenal insufficiency and / or Cushing's syndrome under inhaled corticosteroid therapy during the years 2000 to 2005 |
| Database objective | |
| Main objective | The objectives were to identify cases of adrenal insufficiency and / or Cushing's syndrome in patients taking inhaled corticosteroids during the years 2000 to 2005 and describe the circumstances of occurrence of these events in order to propose recommendations to prevent them. |
| Inclusion criteria | Children or adults treated with inhaled corticosteroids; Having presented symptoms suggestive of adrenal insufficiency and / or Cushing's syndrome during the years 2000 to 2005; First symptoms having appeared during treatment or within 3 months after discontinuation; Patients without adrenal insufficiency and / or Cushing's syndrome known before initiation of treatment with inhaled corticosteroids. |
| Population type | |
| Age |
Infant (28 days to 2 years) Early childhood (2 to 5 years) 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 | Pulmonologists, pediatricians, endocrinologists, emergency physicians in metropolitan France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2005 |
| Date of last collection (YYYY or MM/YYYY) | 2006 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 70 patients éligibles dont 32 patients inclus 70 eligible patients, of whom 32 patients included |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data |
| Clinical data (detail) |
Direct physical measures |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medicines consumption |
| Procedures | |
| Data collection method | Using a questionnaire the physicians reported all patients meeting the inclusion criteria. For each case, a second questionnaire was sent to the physician to collect all treatments taken by the patient including treatment by systemic corticosteroids, as well as clinical and laboratory findings that could clarify the diagnosis and circumstances of event occurrence. |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/18707191 |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | A confidential study report was submitted to the pharmaceutical company. The study report and scientific communications (posters, paper, ...) are validated by the study Scientific Committee. Ownership of study data is the subject of an agreement between the University of Bordeaux Segalen and the pharmaceutical company. Terms for third-party access to the database are to be defined. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
