Efficacy of Inhalation Technique Training.
Impact of Inhalation Technique Training on the Course of Asthma and Chronic Obstructive Pulmonary Disease (COPD).
調査の概要
詳細な説明
Both asthma and COPD are common medical problems. Pharmacologic treatment of asthma and COPD is based mainly on inhalations. The inhalation technique is the key factor for effective management of bronchial obstruction. At the same time, a significant proportion of patients with asthma or COPD do not use inhalers properly.
The aim of the study is:
- to analyze the frequency and type of common mistakes in inhalation technique and
- to determine the impact of short individual training of inhalation technique on the course of asthma and COPD.
Fifty patients with asthma and 50 patients with COPD treated in the out-patient clinic or in the Department of Internal Medicine, Pneumonology and Allergology will be enrolled to the study.
The stage of severity (COPD) and control of the disease (asthma), quality of life, proper inhaler intake will be assessed at the study onset and at a second visit after 6 months.
At the second visit all patients will get a short, individual information about the etiology, course and general treatment plan of asthma / COPD. Patients will be randomized into two groups:
A. group of patients trained in proper inhalation technique B. group of patients without inhalation technique training Control visits will be held 3 and 6 months after training.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Warsaw、ポーランド、02-097
- Department of Internal Medicine, Pneumonology and Allergology, Medical University of Warsaw
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion criteria:
- age of 18 - 80 years
- asthma or COPD diagnosed at least 6 months before study enrollment
- everyday usage of at least one of the following: pressured meter dose inhaler (pMDI) or dry powdered inhaler (Aerolizer, Handihaler, Disc or Turbuhaler)
- no other comorbidities that could influence learning of inhalation technique (psychiatric or neurologic disorders)
Exclusion criteria:
- age less than 18 or above 80 years
- lack of informed consent
- asthma or COPD diagnosed less than 6 months prior to screening visit
- coexistence of respiratory diseases other than asthma or COPD
- irregular use (not every day) of at least one inhaled drug
- treatment with inhalers other than: pMDI, Disc, Turbuhaler, Handihaler or Aerolizer
研究計画
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Education and Inhalation technique training
Training in technique of drug inhalation in asthma and COPD patients and education about the role of inhalation therapy in the course of the disease.
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Training in inhalation technique in asthmatics and COPD patients
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介入なし：Education
Basic education about asthma and COPD.
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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 |
|---|---|---|
|
Asthma or COPD exacerbations
時間枠：6 months
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The number and severity of asthma and COPD exacerbations.
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6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quality of life.
時間枠：baseline, 3 months, 6 months
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Change from baseline in quality of life questionnaires: for asthma patients - Asthma Quality of Life Questionnaire for COPD patients - Saint George's Respiratory Questionnaire |
baseline, 3 months, 6 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Disease control.
時間枠：baseline , 3 months , 6 months
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Change from baseline in Asthma Control Test (ACT) or COPD Assessment Test (CAT)
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baseline , 3 months , 6 months
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Melani AS, Bonavia M, Cilenti V, Cinti C, Lodi M, Martucci P, Serra M, Scichilone N, Sestini P, Aliani M, Neri M; Gruppo Educazionale Associazione Italiana Pneumologi Ospedalieri. Inhaler mishandling remains common in real life and is associated with reduced disease control. Respir Med. 2011 Jun;105(6):930-8. doi: 10.1016/j.rmed.2011.01.005. Epub 2011 Mar 2. Erratum In: Respir Med. 2012 May;106(5):757. DelDonno, Mario [corrected to Del Donno, Mario].
- Press VG, Arora VM, Shah LM, Lewis SL, Charbeneau J, Naureckas ET, Krishnan JA. Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial. J Gen Intern Med. 2012 Oct;27(10):1317-25. doi: 10.1007/s11606-012-2090-9. Epub 2012 May 17.
- Al-Showair RA, Tarsin WY, Assi KH, Pearson SB, Chrystyn H. Can all patients with COPD use the correct inhalation flow with all inhalers and does training help? Respir Med. 2007 Nov;101(11):2395-401. doi: 10.1016/j.rmed.2007.06.008. Epub 2007 Jul 12.
- Dabrowska M, Luczak-Wozniak K, Miszczuk M, Domagala I, Lubanski W, Leszczynski A, Maskey-Warzechowska M, Rubinsztajn R, Hermanowicz-Salamon J, Krenke R. Impact of a Single Session of Inhalation Technique Training on Inhalation Skills and the Course of Asthma and COPD. Respir Care. 2019 Oct;64(10):1250-1260. doi: 10.4187/respcare.06740. Epub 2019 Jun 18.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- WUM-TI
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