INHALER - Cross-sectional study on patients with chronic obstructive pulmonary disease: real-life evaluation of inhaler handling
Head :
Molimard Mathieu, Université de Bordeaux - Department of Medical Pharmacology - CIC Bordeaux CIC1401
Girodet Pierre-Olivier, Université de Bordeaux - Department of Medical Pharmacology - CIC Bordeaux CIC1401
Girodet Pierre-Olivier, Université de Bordeaux - Department of Medical Pharmacology - CIC Bordeaux CIC1401
Last update : 10/27/2017 | Version : 1 | ID : 73245
| General | |
| Identification | |
| Detailed name | Cross-sectional study on patients with chronic obstructive pulmonary disease: real-life evaluation of inhaler handling |
| Sign or acronym | INHALER |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CCTIRS n° 14.615 - CNIL n° 914616 |
| General Aspects | |
| Medical area |
Pneumology |
| Pathology (details) | Chronic obstructive pulmonary disease |
| Health determinants |
Lifestyle and behavior Medicine |
| Keywords | Chronic obstructive pulmonary disease, inhaler handling, Department of Medical Pharmacology, Bordeaux Pharmacoépi, cross-sectional study |
| Scientific investigator(s) (Contact) | |
| Name of the director | Molimard |
| Surname | Mathieu |
| Address |
146 rue Léo Saignat - Case 36 33076 BORDEAUX Cedex |
| Phone | 05 57 57 15 60 |
| mathieu.molimard@u-bordeaux.fr | |
| Unit | Université de Bordeaux - Department of Medical Pharmacology - CIC Bordeaux CIC1401 |
| Organization | Université de Bordeaux |
| Name of the director | Girodet |
| Surname | Pierre-Olivier |
| Address |
146 rue Léo Saignat - Case 36 33076 BORDEAUX |
| Phone | 05 57 57 15 60 |
| pierre-olivier.girodet@u-bordeaux.fr | |
| Unit | Université de Bordeaux - Department of Medical Pharmacology - CIC Bordeaux CIC1401 |
| Organization | Université de Bordeaux |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Novartis Pharma S.A.S. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Université de Bordeaux - Service de Pharmacologie médicale - CIC Bordeaux CIC1401 |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Not-repeated cross-sectional studies (except case control studies) |
| 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. | Patients were included prospectively between March and September 2015 by general practitioners and participating pneumologists. |
| Database objective | |
| Main objective | The main objective is to evaluate the real life handling of inhalers used by patients with obstructive pulmonary disease (COPD). |
| Inclusion criteria |
Diagnosis of COPD
Age over 40 years Smoking over 10 packs per year Use by the patient, for at least 1 month, of a studied inhaler Exclusion criterion Pregnancy |
| 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 |
| Pathology | X - Diseases of the respiratory system |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Private-practice general practitioners and pneumologists in France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2015 |
| Date of last collection (YYYY or MM/YYYY) | 2015 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 5000 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | General characteristics of the patient (sex, age and comorbidities) - History of the COPD |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | 1-Question the patient on his/her history of inhaler use 2- Question the patient on his/her perception of the inhalation carried out 3- Observation of the patient by the physician during the inhalation test |
| Presence of a biobank |
No |
| Health parameters studied |
Health care consumption and services Quality of life/health perception |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Quality of life/perceived health (detail) | Perception of inhalation by the patient (improvement of the respiratory condition) |
| Procedures | |
| Data collection method | Data from the study are collected through standardised paper questionnaires completed by participating physicians. The data are then entered into a specific study database. |
| Participant monitoring |
No |
| Followed pathology | |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | ERJ-01794-2016 - corrected proof.pdf |
| Access | |
| Presence of document that lists variables and coding procedures |
Yes |
| Terms of data access (charter for data provision, format of data, availability delay) | Ownership of and access to the study data were the subject of an agreement between the Université de Bordeaux and the laboratory. The terms of access to the database must be established by a request to the study's scientific advisory board. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
