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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Spa therapy
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring spa therapy

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Private practice: Karim Berkani
  • Private practice: Jean Hérété
  • Private practice: Pierre Ethève
  • Private practice: Marc Bellier
  • Private practice: Pierre Olivier
  • Private practice: Muriel Nouvelle

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard

Spa Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

change in the BODE score
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
C reactive protein (mg/l)
blood work
Eosiniphil count (thou/ml)
blood work
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.
change in the BODE score
change in the BODE score
change in the BODE score
change in the BODE score
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
change in SF36 questionnaire scores
the SF36 quality of life questionnaire
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
Cost (€)
Costs are evaluated from the point of view of payers associated with the pathology.
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.
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.
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.

Full Information

First Posted
February 15, 2011
Last Updated
March 24, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01296854
Brief Title
The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease
Acronym
BPCeaux
Official Title
The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
The feasability of inclusions has proven very low.
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
spa therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard
Arm Type
No Intervention
Arm Description
The patients randomized into this arm of the study will not have spa therapy.
Arm Title
Spa Therapy
Arm Type
Experimental
Arm Description
The patients randomized into this arm of the study will have 3 weeks of spa therapy
Intervention Type
Other
Intervention Name(s)
Spa therapy
Intervention Description
3 weeks of spa therapy
Primary Outcome Measure Information:
Title
Number of exacerbations
Description
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.
Time Frame
12 months after the beginning of treatment
Secondary Outcome Measure Information:
Title
change in the BODE score
Time Frame
3 weeks
Title
change in SF36 questionnaire scores
Description
the SF36 quality of life questionnaire
Time Frame
3 weeks
Title
Cost (€)
Description
Costs are evaluated from the point of view of payers associated with the pathology.
Time Frame
3 weeks
Title
C reactive protein (mg/l)
Description
blood work
Time Frame
3 weeks
Title
Eosiniphil count (thou/ml)
Description
blood work
Time Frame
3 weeks
Title
Number of exacerbations
Description
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.
Time Frame
3 weeks
Title
change in the BODE score
Time Frame
3 months
Title
change in the BODE score
Time Frame
6 months
Title
change in the BODE score
Time Frame
9 months
Title
change in the BODE score
Time Frame
12 months
Title
change in SF36 questionnaire scores
Description
the SF36 quality of life questionnaire
Time Frame
3 months
Title
change in SF36 questionnaire scores
Description
the SF36 quality of life questionnaire
Time Frame
6 months
Title
change in SF36 questionnaire scores
Description
the SF36 quality of life questionnaire
Time Frame
9 months
Title
change in SF36 questionnaire scores
Description
the SF36 quality of life questionnaire
Time Frame
12 months
Title
Cost (€)
Description
Costs are evaluated from the point of view of payers associated with the pathology.
Time Frame
3 months
Title
Cost (€)
Description
Costs are evaluated from the point of view of payers associated with the pathology.
Time Frame
6 months
Title
Cost (€)
Description
Costs are evaluated from the point of view of payers associated with the pathology.
Time Frame
9 months
Title
Cost (€)
Description
Costs are evaluated from the point of view of payers associated with the pathology.
Time Frame
12 months
Title
Number of exacerbations
Description
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.
Time Frame
3 months
Title
Number of exacerbations
Description
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.
Time Frame
6 months
Title
Number of exacerbations
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas Molinari, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jean Victor Hérété, MD
Organizational Affiliation
Amélie les Bains
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private practice: Karim Berkani
City
Aix les Bains
ZIP/Postal Code
73100
Country
France
Facility Name
Private practice: Jean Hérété
City
Amélie les Bains Palalda
ZIP/Postal Code
66110
Country
France
Facility Name
Private practice: Pierre Ethève
City
Briey
ZIP/Postal Code
54150
Country
France
Facility Name
Private practice: Marc Bellier
City
Ceret
ZIP/Postal Code
66400
Country
France
Facility Name
Private practice: Pierre Olivier
City
Perpignan
ZIP/Postal Code
66000
Country
France
Facility Name
Private practice: Muriel Nouvelle
City
Saint Amand les Eaux
ZIP/Postal Code
59230
Country
France

12. IPD Sharing Statement

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The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease

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