The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2014-06-30

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.

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Spa Therapy

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

Group Type EXPERIMENTAL

Spa therapy

Intervention Type OTHER

3 weeks of spa therapy

Interventions

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Spa therapy

3 weeks of spa therapy

Intervention Type OTHER

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

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No