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

Last update : 10/27/2017 | Version : 1 | ID : 73245

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Métadonnées
Identification
General Aspects
Collaborations
Funding
Governance of the database
Scientific investigator(s) (Contact)
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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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
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
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
Email 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
Email pierre-olivier.girodet@u-bordeaux.fr
Unit Université de Bordeaux - Department of Medical Pharmacology - CIC Bordeaux CIC1401
Organization Université de Bordeaux
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
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

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