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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-A00693-36 | Other Identifier | RCB number |
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The feasability of inclusions has proven very low.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard | No Intervention | The patients randomized into this arm of the study will not have spa therapy. | |
| Spa Therapy | Experimental | The patients randomized into this arm of the study will have 3 weeks of spa therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spa therapy | Other | 3 weeks of spa therapy |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in the BODE score | 3 weeks | |
| change in SF36 questionnaire scores | the SF36 quality of life questionnaire | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Molinari, PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Jean Victor Hérété, MD | Amélie les Bains | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private practice: Karim Berkani | Aix-les-Bains | 73100 | France | |||
| Private practice: Jean Hérété |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 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 |
| Amélie Les Bains Palalda |
| 66110 |
| France |
| Private practice: Pierre Ethève | Briey | 54150 | France |
| Private practice: Marc Bellier | Ceret | 66400 | France |
| Private practice: Pierre Olivier | Perpignan | 66000 | France |
| Private practice: Muriel Nouvelle | Saint-Amand-les-Eaux | 59230 | France |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |