Clinical trial NCT01296854: The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease
Official title: The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: spa therapy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-02-16
Enrollment: 39
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of exacerbations
timeFrame: 12 months after the beginning of treatment
Secondary outcomes:
measure: change in the BODE score
timeFrame: 3 weeks
measure: change in SF36 questionnaire scores
timeFrame: 3 weeks
measure: Cost (€)
timeFrame: 3 weeks
measure: C reactive protein (mg/l)
timeFrame: 3 weeks
measure: Eosiniphil count (thou/ml)
timeFrame: 3 weeks
measure: Number of exacerbations
timeFrame: 3 weeks
measure: change in the BODE score
timeFrame: 3 months
measure: change in the BODE score
timeFrame: 6 months
measure: change in the BODE score
timeFrame: 9 months
measure: change in the BODE score
timeFrame: 12 months
measure: change in SF36 questionnaire scores
timeFrame: 3 months
measure: change in SF36 questionnaire scores
timeFrame: 6 months
measure: change in SF36 questionnaire scores
timeFrame: 9 months
measure: change in SF36 questionnaire scores
timeFrame: 12 months
measure: Cost (€)
timeFrame: 3 months
measure: Cost (€)
timeFrame: 6 months
measure: Cost (€)
timeFrame: 9 months
measure: Cost (€)
timeFrame: 12 months
measure: Number of exacerbations
timeFrame: 3 months
measure: Number of exacerbations
timeFrame: 6 months
measure: Number of exacerbations
timeFrame: 9 months
Other outcomes:
Locations:
city: Aix les Bains
country: France
facility: Private practice: Karim Berkani
city: Amélie les Bains Palalda
country: France
facility: Private practice: Jean Hérété
city: Briey
country: France
facility: Private practice: Pierre Ethève
city: Ceret
country: France
facility: Private practice: Marc Bellier
city: Perpignan
country: France
facility: Private practice: Pierre Olivier
city: Saint Amand les Eaux
country: France
facility: Private practice: Muriel Nouvelle
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Nicolas Molinari, PhD
role: STUDY_DIRECTOR
affiliation: Amélie les Bains
name: Jean Victor Hérété, MD
role: PRINCIPAL_INVESTIGATOR
References: