Pulmonary Disease, Chronic Obstructive
Conditions
Keywords
spa therapy
Brief summary
The primary objective of this study is to measure and compare the number of exacerbations (moderate or severe) between the two groups of randomized patients with and without thermal treatment). An exacerbation is defined by an increase in symptoms which justifies a unscheduled medical action: increased daily treatment and / or use of corticosteroids, and / or antibiotic therapy. Exacerbations are documented via prescriptions, hospitalisation reports or unscheduled visits.
Interventions
OTHERSpa therapy
3 weeks of spa therapy
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient must have chronic obstructive pulmonary disease * Obstructive ventilation problem: Tiffeneau index (expiratory volume in one second / slow vital capacity) \< 70% * Expiratory volume in one second \< 80% of the theoretical value * Reversibility \< 12% after inhalation of bronchodilators * Smokers or ex smokers * Available for study monitoring * Has access to diagnostic, medical and therapeutic care according to the best, current criteria (see the recommendations of the French Language Pseumologist Society)
Exclusion criteria
* The patient is participating in another study * The patient has participated in another study in the past 12 months * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is in military service (unavailable for monitoring) * Patient is on parole or otherwise has their liberty restricted by administrative or judiciary decision * The patient is pregnant, or does not have contraception * The patient is breastfeeding * Patient has neoplastic disease * Patient has asthma * Patient has another, evolving pulmonary disease (tuberculosis, pulmonary interstitium disease, active or recent pulmonary infection) * Patient has a clinical history indicating asthma or another respiratory disease (in particular bronchiectasis, pneumoconiosis and other occupational diseases, history of pulmonary neoplasia, HIV, immunosuppressive therapy including corticosteroids in the long term * Patient has respiratory insufficiency * Hypereosinophilic patient (the number of polynuclear eosinophils is \> 0.5 giga/l; confirmed on 2 hemograms) * Recent psychiatric trouble (less than 1 year) * Takes illegal drugs * Patient does not have pneumological care according to the standards set by the French Language Pneumologist Society
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of exacerbations | 12 months after the beginning of treatment | Exacerbation = increase in symptoms (IS) justifying an unprogrammed therapeutic intervention (TI). An IS = increase in \>=2 of the following minor symptoms for \>= 2 consecutive days (CD): (i) dyspnea, (ii) volume or (iii) purulence of sputum. Or an increase in any 1 of the following major symptoms associated with any of the minor symptoms for at least 2 CD: (a) sore throat, (b) cold, (c) fever, (d) coughing, (e) wheezing. A TI = systemic corticoids and/or antibiotics. An exacerbation is defined as severe if TI is accompanied by a hospital stay \> 24h, and as moderate otherwise. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in SF36 questionnaire scores | 3 weeks | the SF36 quality of life questionnaire |
| Cost (€) | 3 weeks | Costs are evaluated from the point of view of payers associated with the pathology. |
| change in the BODE score | 3 weeks | — |
| Eosiniphil count (thou/ml) | 3 weeks | blood work |
| Number of exacerbations | 3 weeks | Exacerbation = increase in symptoms (IS) justifying an unprogrammed therapeutic intervention (TI). An IS = increase in \>=2 of the following minor symptoms for \>= 2 consecutive days (CD): (i) dyspnea, (ii) volume or (iii) purulence of sputum. Or an increase in any 1 of the following major symptoms associated with any of the minor symptoms for at least 2 CD: (a) sore throat, (b) cold, (c) fever, (d) coughing, (e) wheezing. A TI = systemic corticoids and/or antibiotics. An exacerbation is defined as severe if TI is accompanied by a hospital stay \> 24h, and as moderate otherwise. |
| C reactive protein (mg/l) | 3 weeks | blood work |
Countries
France
Outcome results
None listed