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

24 mars 2015 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

39

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

40 år till 80 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Standard
The patients randomized into this arm of the study will not have spa therapy.
Experimentell: Spa Therapy
The patients randomized into this arm of the study will have 3 weeks of spa therapy
Övrig: Spa therapy
3 weeks of spa therapy

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of exacerbations
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Utredare

  • Studierektor: Nicolas Molinari, PhD, Centre Hospitalier Universitaire de Nīmes
  • Huvudutredare: Jean Victor Hérété, MD, Amélie les Bains

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2011

Primärt slutförande (Faktisk)

1 juni 2014

Avslutad studie (Faktisk)

1 juni 2014

Studieregistreringsdatum

Först inskickad

15 februari 2011

Först inskickad som uppfyllde QC-kriterierna

15 februari 2011

Första postat (Uppskatta)

16 februari 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

25 mars 2015

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 mars 2015

Senast verifierad

1 mars 2015

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • LOCAL/2010/NM-02
  • 2010-A00693-36 (Annan identifierare: RCB number)

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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