An interventional study of Spa therapy in Pulmonary Disease, Chronic Obstructive, sponsored by Centre Hospitalier Universitaire de Nīmes. Terminated at 6 sites in France. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-03-25.
Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Treatment
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 39 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The patients randomized into this arm of the study will not have spa therapy.
The patients randomized into this arm of the study will have 3 weeks of spa therapy
Other: Spa therapy
3 weeks of spa therapy
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.
Time frame: 12 months after the beginning of treatment
change in the BODE score
Time frame: 3 weeks
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
Time frame: 3 weeks
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
Time frame: 3 weeks
C reactive protein (mg/l)
blood work
Time frame: 3 weeks
Eosiniphil count (thou/ml)
blood work
Time frame: 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.
Time frame: 3 weeks
change in the BODE score
Time frame: 3 months
change in the BODE score
Time frame: 6 months
change in the BODE score
Time frame: 9 months
change in the BODE score
Time frame: 12 months
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
Time frame: 3 months
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
Time frame: 6 months
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
Time frame: 9 months
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
Time frame: 12 months
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
Time frame: 3 months
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
Time frame: 6 months
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
Time frame: 9 months
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 9 months
This study is terminated, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Nīmes