The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease

NCT01296854 | Terminated DMC

• 2 other identifiers: LOCAL/2010/NM-022010-A00693-36
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

spa therapy

Outcome Measures

Primary Outcomes (1)

• Number of exacerbations

  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

Secondary Outcomes (21)

• change in the BODE score

  3 weeks

• change in SF36 questionnaire scores

  3 weeks

• Cost (€)

  3 weeks

• C reactive protein (mg/l)

  3 weeks

• Eosiniphil count (thou/ml)

  3 weeks

Study Arms (2)

Standard

NO INTERVENTION

The patients randomized into this arm of the study will not have spa therapy.

Spa Therapy

EXPERIMENTAL

The patients randomized into this arm of the study will have 3 weeks of spa therapy

Other: Spa therapy

Interventions

Spa therapy OTHER

3 weeks of spa therapy

Spa Therapy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• The patient is participating in another study
• The patient has participated in another study in the past 12 months
• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (6)

Private practice: Karim Berkani

Aix-les-Bains, 73100, France

Location

Private practice: Jean Hérété

Amélie Les Bains Palalda, 66110, France

Location

Private practice: Pierre Ethève

Briey, 54150, France

Location

Private practice: Marc Bellier

Ceret, 66400, France

Location

Private practice: Pierre Olivier

Perpignan, 66000, France

Location

Private practice: Muriel Nouvelle

Saint-Amand-les-Eaux, 59230, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicolas Molinari, PhD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

• Jean Victor Hérété, MD

  Amélie les Bains

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2011
• First Posted: February 16, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

FR (6)