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

This study has been terminated.
(The feasability of inclusions has proven very low.)
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01296854
First received: February 15, 2011
Last updated: August 21, 2014
Last verified: August 2014
  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:


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.


Enrollment: 39
Study Start Date: May 2011
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
France
Private practice: Karim Berkani
Aix les Bains, France, 73100
Private practice: Jean Hérété
Amélie les Bains Palalda, France, 66110
Private practice: Pierre Ethève
Briey, France, 54150
Private practice: Marc Bellier
Ceret, France, 66400
Private practice: Pierre Olivier
Perpignan, France, 66000
Private practice: Muriel Nouvelle
Saint Amand les Eaux, France, 59230
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: August 21, 2014
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
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 27, 2014