- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01296854
The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease (BPCeaux)
24. März 2015 aktualisiert von: 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.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
39
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Aix les Bains, Frankreich, 73100
- Private practice: Karim Berkani
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Amélie les Bains Palalda, Frankreich, 66110
- Private practice: Jean Hérété
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Briey, Frankreich, 54150
- Private practice: Pierre Ethève
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Ceret, Frankreich, 66400
- Private practice: Marc Bellier
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Perpignan, Frankreich, 66000
- Private practice: Pierre Olivier
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Saint Amand les Eaux, Frankreich, 59230
- Private practice: Muriel Nouvelle
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
40 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Kein Eingriff: Standard
The patients randomized into this arm of the study will not have spa therapy.
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Experimental: Spa Therapy
The patients randomized into this arm of the study will have 3 weeks of spa therapy
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3 weeks of spa therapy
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of exacerbations
Zeitfenster: 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.
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12 months after the beginning of treatment
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
change in the BODE score
Zeitfenster: 3 weeks
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3 weeks
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change in SF36 questionnaire scores
Zeitfenster: 3 weeks
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the SF36 quality of life questionnaire
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3 weeks
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Cost (€)
Zeitfenster: 3 weeks
|
Costs are evaluated from the point of view of payers associated with the pathology.
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3 weeks
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C reactive protein (mg/l)
Zeitfenster: 3 weeks
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blood work
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3 weeks
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Eosiniphil count (thou/ml)
Zeitfenster: 3 weeks
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blood work
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3 weeks
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Number of exacerbations
Zeitfenster: 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.
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3 weeks
|
change in the BODE score
Zeitfenster: 3 months
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3 months
|
|
change in the BODE score
Zeitfenster: 6 months
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6 months
|
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change in the BODE score
Zeitfenster: 9 months
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9 months
|
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change in the BODE score
Zeitfenster: 12 months
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12 months
|
|
change in SF36 questionnaire scores
Zeitfenster: 3 months
|
the SF36 quality of life questionnaire
|
3 months
|
change in SF36 questionnaire scores
Zeitfenster: 6 months
|
the SF36 quality of life questionnaire
|
6 months
|
change in SF36 questionnaire scores
Zeitfenster: 9 months
|
the SF36 quality of life questionnaire
|
9 months
|
change in SF36 questionnaire scores
Zeitfenster: 12 months
|
the SF36 quality of life questionnaire
|
12 months
|
Cost (€)
Zeitfenster: 3 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
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3 months
|
Cost (€)
Zeitfenster: 6 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
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6 months
|
Cost (€)
Zeitfenster: 9 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
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9 months
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Cost (€)
Zeitfenster: 12 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
|
12 months
|
Number of exacerbations
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Studienleiter: Nicolas Molinari, PhD, Centre Hospitalier Universitaire De Nimes
- Hauptermittler: Jean Victor Hérété, MD, Amélie les Bains
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Mai 2011
Primärer Abschluss (Tatsächlich)
1. Juni 2014
Studienabschluss (Tatsächlich)
1. Juni 2014
Studienanmeldedaten
Zuerst eingereicht
15. Februar 2011
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
15. Februar 2011
Zuerst gepostet (Schätzen)
16. Februar 2011
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
25. März 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
24. März 2015
Zuletzt verifiziert
1. März 2015
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- LOCAL/2010/NM-02
- 2010-A00693-36 (Andere Kennung: RCB number)
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
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