PROXAIR - Etude de PROXimologie dans l’Asthme persIstant sévèRe 
Responsable(s) :
Ponthieux Anne, Direction Relations Économiques et Institutionnelles
Date de modification : 05/09/2017 | Version : 1 | ID : 175
| Général | |
| Identification | |
| Nom détaillé | Etude de PROXimologie dans l’Asthme persIstant sévèRe |
| Sigle ou acronyme | PROXAIR |
| Numéro d'enregistrement (ID-RCB ou EUDRACT, CNIL, CPP, etc.) | -- |
| Thématiques générales | |
| Domaine médical |
Pneumology |
| Autres, précisions | severe asthma |
| Mots-clés | asthma control quality of life spouse |
| Responsable(s) scientifique(s) | |
| Nom du responsable | Ponthieux |
| Prénom | Anne |
| Téléphone | +33 (0)1 55 47 64 14 |
| anne.ponthieux@novartis.com | |
| Laboratoire | Direction Relations Économiques et Institutionnelles |
| Organisme | Novartis Pharma |
| Collaborations | |
| Financements | |
| Financements |
Private |
| Précisions | Novartis Pharma S.A.S. |
| Gouvernance de la base de données | |
| Organisation(s) responsable(s) ou promoteur | Novartis Pharma S.A.S. |
| Statut de l’organisation |
Secteur Privé |
| Contact(s) supplémentaire(s) | |
| Caractéristiques | |
| Type de base de données | |
| Type de base de données |
Study databases |
| Base de données issues d'enquêtes, précisions |
Not-repeated cross-sectional studies (except case control studies) |
| Origine du recrutement des participants |
A selection of health care professionals |
| Critère de sélection des participants |
Medication(s) taken |
| Le recrutement dans la base de données s'effectue dans le cadre d'une étude interventionnelle |
No |
| Informations complémentaires concernant la constitution de l'échantillon |
Each investigator propose to all his eligible patients to participate to the study. Patients fill in a questionnaire to assess the impact of his disease on his daily life, and is in chrage to hand over a specific questionnaires his spouse (if his spouse is not present at the consultation). |
| Objectif de la base de données | |
| Objectif principal | Assess physical, psychic and socio-economic impact on patients and spouse of severe persistent asthma treated with high-dose inhaler steroids and long-acting ß2 agonists (LABA), according to the asthma control level |
| Critères d'inclusion |
Patient inclusion Criteria : - Ambulatory patients, able to cooperate, of either sex, at least 18 years of age. - Patients with severe persistent asthma receiving for at least three months a continuous and stable treatment of high-dose inhaler steroids (≥ 1 000 µg/d of beclometasone dipropionate excluding micronized forms in metered-dose inhalers, ≥ 800 µg/d of beclometasone dipropionate in micronized form in metered-dose inhalers or ≥ 800 µg/j of budesonide or ≥ 500 µg/d of fluticasone propionate) and of inhaled long-acting ß2 agonists, administered: either in the form of two specialties using one or two of the following inhalers: Aerolizer®, standard metered-dose inhaler, Autohaler, Diskus®, Turbuhaler®, or in the form of a fixed association using one of the following inhalers: standard metered-dose inhaler, Diskus®, Turbuhaler®. - Patients with FEV measurement in the previous month. - Patients who brought their inhaled steroid treatment and inhaled long-acting ß2-agonist at the time of consultation. - Patients in couple whether or not married - Patients and relatives agree to participate Patient non-inclusion Criteria : - Patients with a non-asthmatic OCPD. - Patients who had inhaled steroids or lLABA treatment change in the previous three months (add-on or change of drug, posology change). - Patients and relatives refusing to participate to the study - Parents/ those close unable to complete a self-questionnaire. - Patients who do not live as a couple |
| Type de population | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population concernée |
General population |
| Sexe |
Male Woman |
| Champ géographique |
National |
| Détail du champ géographique | The study was carried out with a representative sample of pneumologist doctors with a hospital activity (exclusive or mixed) or with a solely liberal activity. The study was proposed by letter to all pneumologists exercising in France: 2089 pneumologists with hospital activity (exclusive or mixed) and 657 liberal pneumologists (Source: TVF, 4 January 2006). |
| Collecte | |
| Dates | |
| Année du premier recueil | 2006 |
| Année du dernier recueil | 2007 |
| Taille de la base de données | |
| Taille de la base de données (en nombre d'individus) |
< 500 individuals |
| Détail du nombre d'individus | 280 |
| Données | |
| Activité de la base |
Data collection completed |
| Type de données recueillies |
Declarative data |
| Données déclaratives, précisions |
Paper self-questionnaire |
| Existence d’une biothèque |
No |
| Paramètres de santé étudiés |
Health event/morbidity Quality of life/health perception |
| Modalités | |
| Mode de recueil des données | self-questionnaire filled in at home and returned by mail |
| Nomenclatures employées | GINA classification |
| Suivi des participants |
No |
| Appariement avec des sources administratives |
No |
| Valorisation et accès | |
| Valorisation et accès | |
| Accès | |
| Charte d'accès aux données (convention de mise à disposition, format de données et délais de mise à disposition) | Methods for accessing the database are currently being defined |
| Accès aux données agrégées |
Access on specific project only |
| Accès aux données individuelles |
Access on specific project only |
