The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease

Not Applicable

Terminated

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Other: Spa therapy

• Registration Number: NCT01296854
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-15
• Study First Submitted QC: 2011-02-15
• Study First Posted: 2011-02-16
• Study Start: 2011-05
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spa Therapy	Spa therapy	The patients randomized into this arm of the study will have 3 weeks of spa therapy

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (6)

Private practice: Jean Hérété; 🇫🇷 Amélie les Bains Palalda, France

Private practice: Karim Berkani; 🇫🇷 Aix les Bains, France

Private practice: Marc Bellier; 🇫🇷 Ceret, France

Private practice: Pierre Olivier; 🇫🇷 Perpignan, France

Private practice: Pierre Ethève; 🇫🇷 Briey, France

Private practice: Muriel Nouvelle; 🇫🇷 Saint Amand les Eaux, France