The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 6
- 主要终点
- Number of exacerbations
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Standard
The patients randomized into this arm of the study will not have spa therapy.
Spa Therapy
The patients randomized into this arm of the study will have 3 weeks of spa therapy
干预措施: Spa therapy (Other)
结局指标
主要结局
Number of exacerbations
时间窗: 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.
次要结局
- C reactive protein (mg/l)(3 weeks)
- change in SF36 questionnaire scores(12 months)
- Number of exacerbations(9 months)
- change in the BODE score(12 months)
- Cost (€)(12 months)
- Eosiniphil count (thou/ml)(3 weeks)
- change in the BODE score(3 weeks)
- change in SF36 questionnaire scores(3 weeks)
- Cost (€)(3 weeks)
- change in SF36 questionnaire scores(9 months)
- Number of exacerbations(3 weeks)
- change in the BODE score(3 months)
- change in the BODE score(6 months)
- change in the BODE score(9 months)
- change in SF36 questionnaire scores(3 months)
- change in SF36 questionnaire scores(6 months)
- Cost (€)(3 months)
- Cost (€)(6 months)
- Cost (€)(9 months)
- Number of exacerbations(3 months)
- Number of exacerbations(6 months)