The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease

Conditions
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Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
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* Other: Spa therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard<br>The patients randomized into this arm of the study will not have spa therapy. | |
| Experimental: Spa Therapy<br>The patients randomized into this arm of the study will have 3 weeks of spa therapy | Other: Spa therapy<br>* 3 weeks of spa therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of exacerbations | 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. | 12 months after the beginning of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the BODE score |  | 3 weeks | 
| change in SF36 questionnaire scores | the SF36 quality of life questionnaire | 3 weeks | 
| Cost (€) | Costs are evaluated from the point of view of payers associated with the pathology. | 3 weeks | 
| C reactive protein (mg/l) | blood work | 3 weeks | 
| Eosiniphil count (thou/ml) | blood work | 3 weeks | 
| Number of exacerbations | 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. | 3 weeks | 
| change in the BODE score |  | 3 months | 
| change in the BODE score |  | 6 months | 
| change in the BODE score |  | 9 months | 
| change in the BODE score |  | 12 months | 
| change in SF36 questionnaire scores | the SF36 quality of life questionnaire | 3 months | 
| change in SF36 questionnaire scores | the SF36 quality of life questionnaire | 6 months | 
| change in SF36 questionnaire scores | the SF36 quality of life questionnaire | 9 months | 
| change in SF36 questionnaire scores | the SF36 quality of life questionnaire | 12 months | 
| Cost (€) | Costs are evaluated from the point of view of payers associated with the pathology. | 3 months | 
| Cost (€) | Costs are evaluated from the point of view of payers associated with the pathology. | 6 months | 
| Cost (€) | Costs are evaluated from the point of view of payers associated with the pathology. | 9 months | 
| Cost (€) | Costs are evaluated from the point of view of payers associated with the pathology. | 12 months | 
| Number of exacerbations | 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. | 3 months | 
| Number of exacerbations | 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. | 6 months | 
| Number of exacerbations | 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. | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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spa therapy