- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01296854
The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease (BPCeaux)
24 marzo 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Terminato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
39
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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-
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Aix les Bains, Francia, 73100
- Private practice: Karim Berkani
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Amélie les Bains Palalda, Francia, 66110
- Private practice: Jean Hérété
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Briey, Francia, 54150
- Private practice: Pierre Ethève
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Ceret, Francia, 66400
- Private practice: Marc Bellier
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Perpignan, Francia, 66000
- Private practice: Pierre Olivier
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Saint Amand les Eaux, Francia, 59230
- Private practice: Muriel Nouvelle
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 40 anni a 80 anni (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: Standard
The patients randomized into this arm of the study will not have spa therapy.
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|
Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of exacerbations
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
change in the BODE score
Lasso di tempo: 3 weeks
|
3 weeks
|
|
change in SF36 questionnaire scores
Lasso di tempo: 3 weeks
|
the SF36 quality of life questionnaire
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3 weeks
|
Cost (€)
Lasso di tempo: 3 weeks
|
Costs are evaluated from the point of view of payers associated with the pathology.
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3 weeks
|
C reactive protein (mg/l)
Lasso di tempo: 3 weeks
|
blood work
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3 weeks
|
Eosiniphil count (thou/ml)
Lasso di tempo: 3 weeks
|
blood work
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3 weeks
|
Number of exacerbations
Lasso di tempo: 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
Lasso di tempo: 3 months
|
3 months
|
|
change in the BODE score
Lasso di tempo: 6 months
|
6 months
|
|
change in the BODE score
Lasso di tempo: 9 months
|
9 months
|
|
change in the BODE score
Lasso di tempo: 12 months
|
12 months
|
|
change in SF36 questionnaire scores
Lasso di tempo: 3 months
|
the SF36 quality of life questionnaire
|
3 months
|
change in SF36 questionnaire scores
Lasso di tempo: 6 months
|
the SF36 quality of life questionnaire
|
6 months
|
change in SF36 questionnaire scores
Lasso di tempo: 9 months
|
the SF36 quality of life questionnaire
|
9 months
|
change in SF36 questionnaire scores
Lasso di tempo: 12 months
|
the SF36 quality of life questionnaire
|
12 months
|
Cost (€)
Lasso di tempo: 3 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
|
3 months
|
Cost (€)
Lasso di tempo: 6 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
|
6 months
|
Cost (€)
Lasso di tempo: 9 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
|
9 months
|
Cost (€)
Lasso di tempo: 12 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
|
12 months
|
Number of exacerbations
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Investigatori
- Direttore dello studio: Nicolas Molinari, PhD, Centre Hospitalier Universitaire de Nīmes
- Investigatore principale: Jean Victor Hérété, MD, Amélie les Bains
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 maggio 2011
Completamento primario (Effettivo)
1 giugno 2014
Completamento dello studio (Effettivo)
1 giugno 2014
Date di iscrizione allo studio
Primo inviato
15 febbraio 2011
Primo inviato che soddisfa i criteri di controllo qualità
15 febbraio 2011
Primo Inserito (Stima)
16 febbraio 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
25 marzo 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 marzo 2015
Ultimo verificato
1 marzo 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- LOCAL/2010/NM-02
- 2010-A00693-36 (Altro identificatore: RCB number)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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