The Effect of Spa Treatment on Chronic Obstructive Pulmonary Disease (BPCeaux)
2015年3月24日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
39
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Aix les Bains、フランス、73100
- Private practice: Karim Berkani
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Amélie les Bains Palalda、フランス、66110
- Private practice: Jean Hérété
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Briey、フランス、54150
- Private practice: Pierre Ethève
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Ceret、フランス、66400
- Private practice: Marc Bellier
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Perpignan、フランス、66000
- Private practice: Pierre Olivier
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Saint Amand les Eaux、フランス、59230
- Private practice: Muriel Nouvelle
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
40年～80年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
介入なし：Standard
The patients randomized into this arm of the study will not have spa therapy.
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Number of exacerbations
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
change in the BODE score
時間枠：3 weeks
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3 weeks
|
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change in SF36 questionnaire scores
時間枠：3 weeks
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the SF36 quality of life questionnaire
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3 weeks
|
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Cost (€)
時間枠：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)
時間枠：3 weeks
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blood work
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3 weeks
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Eosiniphil count (thou/ml)
時間枠：3 weeks
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blood work
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3 weeks
|
|
Number of exacerbations
時間枠：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
|
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change in the BODE score
時間枠：3 months
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3 months
|
|
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change in the BODE score
時間枠：6 months
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6 months
|
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change in the BODE score
時間枠：9 months
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9 months
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change in the BODE score
時間枠：12 months
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12 months
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change in SF36 questionnaire scores
時間枠：3 months
|
the SF36 quality of life questionnaire
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3 months
|
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change in SF36 questionnaire scores
時間枠：6 months
|
the SF36 quality of life questionnaire
|
6 months
|
|
change in SF36 questionnaire scores
時間枠：9 months
|
the SF36 quality of life questionnaire
|
9 months
|
|
change in SF36 questionnaire scores
時間枠：12 months
|
the SF36 quality of life questionnaire
|
12 months
|
|
Cost (€)
時間枠：3 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
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3 months
|
|
Cost (€)
時間枠：6 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
|
6 months
|
|
Cost (€)
時間枠：9 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
|
9 months
|
|
Cost (€)
時間枠：12 months
|
Costs are evaluated from the point of view of payers associated with the pathology.
|
12 months
|
|
Number of exacerbations
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- スタディディレクター：Nicolas Molinari, PhD、Centre Hospitalier Universitaire de Nîmes
- 主任研究者：Jean Victor Hérété, MD、Amélie les Bains
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年5月1日
一次修了 (実際)
2014年6月1日
研究の完了 (実際)
2014年6月1日
試験登録日
最初に提出
2011年2月15日
QC基準を満たした最初の提出物
2011年2月15日
最初の投稿 (見積もり)
2011年2月16日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年3月25日
QC基準を満たした最後の更新が送信されました
2015年3月24日
最終確認日
2015年3月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- LOCAL/2010/NM-02
- 2010-A00693-36 (その他の識別子：RCB number)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。