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

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.

Study Overview

• Status: Terminated
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Other: Spa therapy

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Aix les Bains, France, 73100
    • Private practice: Karim Berkani
  • Amélie les Bains Palalda, France, 66110
    • Private practice: Jean Hérété
  • Briey, France, 54150
    • Private practice: Pierre Ethève
  • Ceret, France, 66400
    • Private practice: Marc Bellier
  • Perpignan, France, 66000
    • Private practice: Pierre Olivier
  • Saint Amand les Eaux, France, 59230
    • Private practice: Muriel Nouvelle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard; The patients randomized into this arm of the study will not have spa therapy.
Experimental: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months after the beginning of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in the BODE score		3 weeks
change in SF36 questionnaire scores	the SF36 quality of life questionnaire	3 weeks
Cost (€)	Costs are evaluated from the point of view of payers associated with the pathology.	3 weeks
C reactive protein (mg/l)	blood work	3 weeks
Eosiniphil count (thou/ml)	blood work	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.	3 weeks
change in the BODE score		3 months
change in the BODE score		6 months
change in the BODE score		9 months
change in the BODE score		12 months
change in SF36 questionnaire scores	the SF36 quality of life questionnaire	3 months
change in SF36 questionnaire scores	the SF36 quality of life questionnaire	6 months
change in SF36 questionnaire scores	the SF36 quality of life questionnaire	9 months
change in SF36 questionnaire scores	the SF36 quality of life questionnaire	12 months
Cost (€)	Costs are evaluated from the point of view of payers associated with the pathology.	3 months
Cost (€)	Costs are evaluated from the point of view of payers associated with the pathology.	6 months
Cost (€)	Costs are evaluated from the point of view of payers associated with the pathology.	9 months
Cost (€)	Costs are evaluated from the point of view of payers associated with the pathology.	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.	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.	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.	9 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Study Director: Nicolas Molinari, PhD, Centre Hospitalier Universitaire de Nīmes; Principal Investigator: Jean Victor Hérété, MD, Amélie les Bains

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: February 15, 2011
• First Submitted That Met QC Criteria: February 15, 2011
• First Posted (Estimate): February 16, 2011

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: spa therapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: LOCAL/2010/NM-02; 2010-A00693-36 (Other Identifier: RCB number)