The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease (BPCeaux)

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Other: Spa therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01296854

LOCAL/2010/NM-02

2010-A00693-36 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 2 patient groups

Standard

No Intervention group

Description:

The patients randomized into this arm of the study will not have spa therapy.

Spa Therapy

Experimental group

Description:

The patients randomized into this arm of the study will have 3 weeks of spa therapy

Treatment:

Other: Spa therapy