ITMO public health
Last update : 09/05/2017 | Version : 1 | ID : 175
| General | |
| Identification | |
| Detailed name | Etude de PROXimologie dans l’Asthme persIstant sévèRe |
| Sign or acronym | PROXAIR |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | -- |
| General Aspects | |
| Medical area |
Pneumology |
| Others (details) | severe asthma |
| Keywords | asthma control quality of life spouse |
| Scientific investigator(s) (Contact) | |
| Name of the director | Ponthieux |
| Surname | Anne |
| Phone | +33 (0)1 55 47 64 14 |
| anne.ponthieux@novartis.com | |
| Unit | Direction Relations Économiques et Institutionnelles |
| Organization | Novartis Pharma |
| Collaborations | |
| Funding | |
| Funding status |
Private |
| Details | Novartis Pharma S.A.S. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Novartis Pharma S.A.S. |
| Organisation status |
Private |
| 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. |
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). |
| Database objective | |
| Main objective | 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 |
| Inclusion criteria |
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 |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) |
| Population covered |
General population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | 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). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 2006 |
| Date of last collection (YYYY or MM/YYYY) | 2007 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 280 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Declarative data |
| Declarative data (detail) |
Paper self-questionnaire |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Quality of life/health perception |
| Procedures | |
| Data collection method | self-questionnaire filled in at home and returned by mail |
| Classifications used | GINA classification |
| Participant monitoring |
No |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Methods for accessing the database are currently being defined |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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