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

24 maart 2015 bijgewerkt door: Centre Hospitalier Universitaire de Nīmes
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.

Studie Overzicht

Toestand

Beëindigd

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

39

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

40 jaar tot 80 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Standard
The patients randomized into this arm of the study will not have spa therapy.
Experimenteel: Spa Therapy
The patients randomized into this arm of the study will have 3 weeks of spa therapy
Ander: Spa therapy
3 weeks of spa therapy

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of exacerbations
Tijdsspanne: 12 months after the beginning of treatment
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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
change in the BODE score
Tijdsspanne: 3 weeks
3 weeks
change in SF36 questionnaire scores
Tijdsspanne: 3 weeks
the SF36 quality of life questionnaire
3 weeks
Cost (€)
Tijdsspanne: 3 weeks
Costs are evaluated from the point of view of payers associated with the pathology.
3 weeks
C reactive protein (mg/l)
Tijdsspanne: 3 weeks
blood work
3 weeks
Eosiniphil count (thou/ml)
Tijdsspanne: 3 weeks
blood work
3 weeks
Number of exacerbations
Tijdsspanne: 3 weeks
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
Tijdsspanne: 3 months
3 months
change in the BODE score
Tijdsspanne: 6 months
6 months
change in the BODE score
Tijdsspanne: 9 months
9 months
change in the BODE score
Tijdsspanne: 12 months
12 months
change in SF36 questionnaire scores
Tijdsspanne: 3 months
the SF36 quality of life questionnaire
3 months
change in SF36 questionnaire scores
Tijdsspanne: 6 months
the SF36 quality of life questionnaire
6 months
change in SF36 questionnaire scores
Tijdsspanne: 9 months
the SF36 quality of life questionnaire
9 months
change in SF36 questionnaire scores
Tijdsspanne: 12 months
the SF36 quality of life questionnaire
12 months
Cost (€)
Tijdsspanne: 3 months
Costs are evaluated from the point of view of payers associated with the pathology.
3 months
Cost (€)
Tijdsspanne: 6 months
Costs are evaluated from the point of view of payers associated with the pathology.
6 months
Cost (€)
Tijdsspanne: 9 months
Costs are evaluated from the point of view of payers associated with the pathology.
9 months
Cost (€)
Tijdsspanne: 12 months
Costs are evaluated from the point of view of payers associated with the pathology.
12 months
Number of exacerbations
Tijdsspanne: 3 months
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
Tijdsspanne: 6 months
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
Tijdsspanne: 9 months
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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Onderzoekers

  • Studie directeur: Nicolas Molinari, PhD, Centre Hospitalier Universitaire de Nîmes
  • Hoofdonderzoeker: Jean Victor Hérété, MD, Amélie les Bains

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2011

Primaire voltooiing (Werkelijk)

1 juni 2014

Studie voltooiing (Werkelijk)

1 juni 2014

Studieregistratiedata

Eerst ingediend

15 februari 2011

Eerst ingediend dat voldeed aan de QC-criteria

15 februari 2011

Eerst geplaatst (Schatting)

16 februari 2011

Updates van studierecords

Laatste update geplaatst (Schatting)

25 maart 2015

Laatste update ingediend die voldeed aan QC-criteria

24 maart 2015

Laatst geverifieerd

1 maart 2015

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • LOCAL/2010/NM-02
  • 2010-A00693-36 (Andere identificatie: RCB number)

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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