Effect of Bronchial Thermoplasty on Moderate Bronchial Asthma in China
2016年11月14日 更新者：ShiYue Li、Guangzhou Institute of Respiratory Disease
This study aims to investigate the efficacy and safety of Bronchial Thermoplasty on moderate bronchial asthma in China, by observing the improvement of quality of life, the decrease of acute attack and emergence, as well as the incidence of related complications.
調査の概要
詳細な説明
This is a multi-center, open-label and single arm study. At least 50 patients with moderate asthma receive Bronchial Thermoplasty for three times. Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ), Frequency of mild asthma acute attack, PEF, FEV1, Emergency and Hospitalization are compared between before and after BT treatment.
The unified peak flow test meter will be provided to all subjects enrolled in this study. They will get a follow-up diary book before leaving hospital. In order to ensure the efficiency, all enrolled asthma patients are trained and tested by doctors and nurses from in-patient or out-patient department when they follow up, including how to use the PEF meter, how to read and record the data. As for the dosage of medication, all the medication uses are followed the doctor's advice, once the rescue medications were used, the times and dosages are mandatory to be recorded in the diary book by the patients themselves.
研究の種類
介入
入学 (予想される)
50
段階
- フェーズ2
- フェーズ 1
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
-
-
Guangdong
-
Guangzhou、Guangdong、中国、510000
- 募集
- Guangzhou Institute of Respiratory Disease
-
コンタクト：
- yanqiuzi cheng
- 電話番号：15915709477
- メール：736145682@qq.com
-
-
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
18年～65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:
- age between 18y and 65y.
- no improvement after ICS and LABA treatment in patients with moderate asthma
- have not received BT before
- stable more than 6 weeks before enrolled in this study
- no implantable electrical device (e.g. cardiac pacemaker)
- no permanent anticoagulant is being used
Exclusion Criteria:
- Smoking and have obvious emphysema
- Chest CT showed lower lobe bronchial stenosis or distal complete atelectasis
- FEV1 < 65% predicted value after using bronchodilator
- airway infection(within 6 weeks)
- any circumstances as the following within the past 1 year: lower respiratory tract infection (LRTI) for 4 times or above; hospitalization due to respiratory diseases for more than 3 times; increase the dosage of oral corticosteroids due to asthma exacerbation for more than 4 times
- received endotracheal intubation or ICU admission due to asthma attack within the past 2 years
- concomitant allergic bronchopulmonary aspergillosis
- Implantable electronic devices (such as cardiac pacemaker)/NYHA class IV and/or acute myocardial infarction within the past 3 months
- coagulation disorders,cannot stop taking anticoagulant、antiplatelet drugs or nonsteroidal anti-inflammatory drugs
- increasing the risk of adverse reactions during bronchoscopy or anesthesia as the followings: pregnancy, insulin-dependent diabetes, epilepsy, or the other severe complications, such as uncontrolled coronary heart disease, acute or chronic renal failure or uncontrolled hypertension
- others:vocal cord dysfunction、chronic nasosinusitis、airway obstruction or uncontrolled obstructive sleep apnea syndrome
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：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Bronchial Thermoplasty
Moderate bronchial asthma patients under the Bronchial Thermoplasty.
|
patients will be under Bronchial Thermoplasty approximately every three weeks.And totally having three surgerys will be considered as completed.
|
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 |
時間枠 |
|---|---|
|
change from baseline2 AQLQ score after Bronchial Thermoplasty
時間枠：baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
decline from baseline 2 in the ACQ score for 0.5 or more
時間枠：baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
|
|
Frequency of mild asthma acute execration after Bronchial Thermoplasty
時間枠：baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
A mild exacerbation is defined as 2 consecutive days when at least one of the following occurs:1. Morning peak expiratory flow falls at least 20% below the average morning peak flow recorded at the baseline (the first 2 weeks during the 4-week baseline period). 2. More than 3 more puffs of rescue short acting bronchodilator are required than the average usage at the baseline(the first 2 weeks during the 4-week baseline period). 3. Awakening at night with asthma symptoms. |
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
|
change from baseline2 peak flow after Bronchial Thermoplasty
時間枠：baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
|
|
change from baseline2 FEV1 after Bronchial Thermoplasty
時間枠：baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
|
|
change from baseline2 FEV1/FVC after Bronchial Thermoplasty
時間枠：baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
|
|
change from baseline2 FEV1 predicted after Bronchial Thermoplasty
時間枠：baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
|
|
the percentage of Emergency
時間枠：baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
|
|
Hospitalization and Asymptomatic days
時間枠：baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
|
|
the incidence of severe respiratory adverse events
時間枠：baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
baseline2、6 weeks after the third surgery、3、6、9 、12 months after the third surgery and stoping laba for 2 weeks
|
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
- 主任研究者：shiyue li, director、Guangzhou Institute of Respiratory Disease
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Solway J, Irvin CG. Airway smooth muscle as a target for asthma therapy. N Engl J Med. 2007 Mar 29;356(13):1367-9. doi: 10.1056/NEJMe078005. No abstract available.
- Danek CJ, Lombard CM, Dungworth DL, Cox PG, Miller JD, Biggs MJ, Keast TM, Loomas BE, Wizeman WJ, Hogg JC, Leff AR. Reduction in airway hyperresponsiveness to methacholine by the application of RF energy in dogs. J Appl Physiol (1985). 2004 Nov;97(5):1946-53. doi: 10.1152/japplphysiol.01282.2003. Epub 2004 Jul 16.
- Lai CK, De Guia TS, Kim YY, Kuo SH, Mukhopadhyay A, Soriano JB, Trung PL, Zhong NS, Zainudin N, Zainudin BM; Asthma Insights and Reality in Asia-Pacific Steering Committee. Asthma control in the Asia-Pacific region: the Asthma Insights and Reality in Asia-Pacific Study. J Allergy Clin Immunol. 2003 Feb;111(2):263-8. doi: 10.1067/mai.2003.30.
- Miller JD, Cox G, Vincic L, Lombard CM, Loomas BE, Danek CJ. A prospective feasibility study of bronchial thermoplasty in the human airway. Chest. 2005 Jun;127(6):1999-2006. doi: 10.1378/chest.127.6.1999.
- Cox G, Thomson NC, Rubin AS, Niven RM, Corris PA, Siersted HC, Olivenstein R, Pavord ID, McCormack D, Chaudhuri R, Miller JD, Laviolette M; AIR Trial Study Group. Asthma control during the year after bronchial thermoplasty. N Engl J Med. 2007 Mar 29;356(13):1327-37. doi: 10.1056/NEJMoa064707.
- Pavord ID, Cox G, Thomson NC, Rubin AS, Corris PA, Niven RM, Chung KF, Laviolette M; RISA Trial Study Group. Safety and efficacy of bronchial thermoplasty in symptomatic, severe asthma. Am J Respir Crit Care Med. 2007 Dec 15;176(12):1185-91. doi: 10.1164/rccm.200704-571OC. Epub 2007 Sep 27.
- Castro M, Rubin A, Laviolette M, Hanania NA, Armstrong B, Cox G; AIR2 Trial Study Group. Persistence of effectiveness of bronchial thermoplasty in patients with severe asthma. Ann Allergy Asthma Immunol. 2011 Jul;107(1):65-70. doi: 10.1016/j.anai.2011.03.005. Epub 2011 Apr 14.
- Cox G, Miller JD, McWilliams A, Fitzgerald JM, Lam S. Bronchial thermoplasty for asthma. Am J Respir Crit Care Med. 2006 May 1;173(9):965-9. doi: 10.1164/rccm.200507-1162OC. Epub 2006 Feb 2.
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
2015年2月1日
一次修了 (予想される)
2017年12月1日
研究の完了 (予想される)
2017年12月1日
試験登録日
最初に提出
2016年11月9日
QC基準を満たした最初の提出物
2016年11月14日
最初の投稿 (見積もり)
2016年11月17日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年11月17日
QC基準を満たした最後の更新が送信されました
2016年11月14日
最終確認日
2016年11月1日
詳しくは
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。