The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease

Pulmonary Disease, Chronic Obstructive Clinical Trial

— BPCeaux  

Official title:

The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01296854
• Other study ID #: LOCAL/2010/NM-02
• Secondary ID: 2010-A00693-36
• Status: Terminated
• Phase: N/A
• First received: February 15, 2011
• Last updated: March 24, 2015
• Start date: May 2011
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Spa therapy
3 weeks of spa therapy

Locations

Country	Name	City	State
France	Private practice: Karim Berkani	Aix les Bains
France	Private practice: Jean Hérété	Amélie les Bains Palalda
France	Private practice: Pierre Ethève	Briey
France	Private practice: Marc Bellier	Ceret
France	Private practice: Pierre Olivier	Perpignan
France	Private practice: Muriel Nouvelle	Saint Amand les Eaux

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	change in the BODE score		3 weeks	No
Secondary	change in SF36 questionnaire scores	the SF36 quality of life questionnaire	3 weeks	No
Secondary	Cost (€)	Costs are evaluated from the point of view of payers associated with the pathology.	3 weeks	No
Secondary	C reactive protein (mg/l)	blood work	3 weeks	No
Secondary	Eosiniphil count (thou/ml)	blood work	3 weeks	No
Secondary	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	Yes
Secondary	change in the BODE score		3 months	No
Secondary	change in the BODE score		6 months	No
Secondary	change in the BODE score		9 months	No
Secondary	change in the BODE score		12 months	No
Secondary	change in SF36 questionnaire scores	the SF36 quality of life questionnaire	3 months	No
Secondary	change in SF36 questionnaire scores	the SF36 quality of life questionnaire	6 months	No
Secondary	change in SF36 questionnaire scores	the SF36 quality of life questionnaire	9 months	No
Secondary	change in SF36 questionnaire scores	the SF36 quality of life questionnaire	12 months	No
Secondary	Cost (€)	Costs are evaluated from the point of view of payers associated with the pathology.	3 months	No
Secondary	Cost (€)	Costs are evaluated from the point of view of payers associated with the pathology.	6 months	No
Secondary	Cost (€)	Costs are evaluated from the point of view of payers associated with the pathology.	9 months	No
Secondary	Cost (€)	Costs are evaluated from the point of view of payers associated with the pathology.	12 months	No
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes