The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease - Full Text View

Purpose

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.

Condition	Intervention
Pulmonary Disease, Chronic Obstructive	Other: Spa therapy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:

Number of exacerbations [ Time Frame: 12 months after the beginning of treatment ] [ Designated as safety issue: Yes ]
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:

change in the BODE score [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
change in SF36 questionnaire scores [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
the SF36 quality of life questionnaire
Cost (€) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Costs are evaluated from the point of view of payers associated with the pathology.
C reactive protein (mg/l) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
blood work
Eosiniphil count (thou/ml) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
blood work
Number of exacerbations [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 3 months ] [ Designated as safety issue: No ]
change in the BODE score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
change in the BODE score [ Time Frame: 9 months ] [ Designated as safety issue: No ]
change in the BODE score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
change in SF36 questionnaire scores [ Time Frame: 3 months ] [ Designated as safety issue: No ]
the SF36 quality of life questionnaire
change in SF36 questionnaire scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
the SF36 quality of life questionnaire
change in SF36 questionnaire scores [ Time Frame: 9 months ] [ Designated as safety issue: No ]
the SF36 quality of life questionnaire
change in SF36 questionnaire scores [ Time Frame: 12 months ] [ Designated as safety issue: No ]
the SF36 quality of life questionnaire
Cost (€) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Costs are evaluated from the point of view of payers associated with the pathology.
Cost (€) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Costs are evaluated from the point of view of payers associated with the pathology.
Cost (€) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Costs are evaluated from the point of view of payers associated with the pathology.
Cost (€) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Costs are evaluated from the point of view of payers associated with the pathology.
Number of exacerbations [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
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.
Number of exacerbations [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
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.
Number of exacerbations [ Time Frame: 9 months ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	334
Study Start Date:	May 2011
Estimated Study Completion Date:	May 2015
Estimated Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296854

Contacts

Contact: Nicolas M Molinari, PhD	33.4.66.68.34.03	nicolas.molinari@inserm.fr
Contact: Carey M Suehs	3466686788	carey.suehs@chu-nimes.fr

Locations

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

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

Study Director:	Nicolas Molinari, PhD	Centre Hospitalier Universitaire de Nîmes
Principal Investigator:	Jean Victor Hérété, MD	Amélie les Bains

More Information

No publications provided

Responsible Party:	Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:	NCT01296854 History of Changes
Other Study ID Numbers:	LOCAL/2010/NM-02, 2010-A00693-36
Study First Received:	February 15, 2011
Last Updated:	March 22, 2013
Health Authority:	France: Committee for the Protection of Personnes France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire de Nīmes:

spa therapy

Additional relevant MeSH terms:

Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on June 18, 2013

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