Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma
2020年10月24日 更新者：yanfugui、Second Affiliated Hospital, School of Medicine, Zhejiang University
Asthma, abbreviation for bronchial asthma, is one of the common chronic airways disease that threatens human health.
Typical symptoms of asthma are recurrent wheezing, shortness of breath, chest tightness and cough, usually occurring at night or early morning.
However, there are still some patients with only persistent clinical manifestations of chest tightness.
Concerned about this group of patients, we presented a subgroup of bronchial asthma, namely, chest tightness variant asthma (CTVA).
This asthma subgroup usually lacks asthma-specific clinical features such as wheezing, shortness of breath, wheezing, and therefore often misdiagnosed for a long time.
In order to further understand the clinical characteristics, pathogenesis, and prognosis of patients with CTVA, we conducted a national multicenter observation study to further understand CTVA.
Finally, we plan to clarify whether CTVA is a relatively independent asthma phenotype.
Meanwhile, reducing misdiagnosis and perform an appropriate treatment of CTVA.
研究概览
地位
完全的
研究类型
观察性的
注册 (实际的)
76
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Beijing
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Beijing、Beijing、中国
- China-Japan Friendship Hospital
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Beijing、Beijing、中国
- Beijing Tongren Hospital, Capital Medical University
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Beijing、Beijing、中国
- Beijing Chao-Yang Hospital
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Chongqing
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Chongqing、Chongqing、中国
- Xinqiao Hospital，Third Military Medical University
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Fujian
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Fuzhou、Fujian、中国
- The Second Affiliated Hospital，Fujian Medical University
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Guangdong
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Guangzhou、Guangdong、中国
- The First Affiliated Hospital,Guangzhou Medical University
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Guangzhou、Guangdong、中国
- Nanfang Hospital, Nanfang Medical University
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Shenzhen、Guangdong、中国
- People's Hospital of Shenzhen
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Zhanjiang、Guangdong、中国
- Affiliated Hospital,Zhanjiang Medical College
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Guizhou
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Guiyang、Guizhou、中国
- Guizhou Provincial People's Hospital
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Henan
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Zhengzhou、Henan、中国
- Henan Provincial People's Hospital
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Hubei
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Wuhan、Hubei、中国
- Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
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Hunan
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Changsha、Hunan、中国
- The Second Xiangya Hospital of Central South University
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Changsha、Hunan、中国
- Xiangya Hospital of Central South University
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Jiangsu
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Nanjing、Jiangsu、中国
- Jiangsu Province Hospital
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Liaoning
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Shenyang、Liaoning、中国
- The Central Hospital of Shenyang Military
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Shenyang、Liaoning、中国
- The First Affiliated Hospital, China Medical University
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Shaanxi
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Xi'an、Shaanxi、中国
- Xijing Hospital
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Shandong
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Jinan、Shandong、中国
- Qilu Hospital, Shandong University
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Jinan、Shandong、中国
- Shandong Provincal Hospital
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Qingdao、Shandong、中国
- Qingdao Municipal Hospital
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Weifang、Shandong、中国
- Weifang Asthma Hospital
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Yantai、Shandong、中国
- Yantai liuhuanding Hospital
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Shanghai
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Shanghai、Shanghai、中国
- Zhongshan Hospital, Fudan University
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Shanghai、Shanghai、中国
- Changhai Hospital, Second Military Medical University
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Shanghai、Shanghai、中国
- Ruijin Hospital, Shanghai Jiaotong University
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Shanghai、Shanghai、中国
- No.1 Hospital, Shanghai Jiaotong University
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Shanghai、Shanghai、中国
- Tongji Hospital, Tongji University
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Shanghai、Shanghai、中国
- Xinhua Hospital, Shanghai Jiaotong University
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Sichuan
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Chengdu、Sichuan、中国
- West China Hospital,Sichuan University
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Zhejiang
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Hangzhou、Zhejiang、中国
- Sir Run Run Shaw hospital, College of Medicine，Zhejiang University
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Hanzhou、Zhejiang、中国、310000
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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Huzhou、Zhejiang、中国
- Huzhou Central Hospital
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Wenzhou、Zhejiang、中国
- The Second Affiliated Hospital,Wenzhou Medical University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
14年 至 80年 (孩子、成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Patients with only symptom of chest tightness and bronchial provocation test positive according to eligibility criteria.
描述
Inclusion Criteria:
- all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent;
- the age of more than 14 and less 80 years old, gender and ethnicity are not limited;
- the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough;
- no wheezing;
a diagnosis of asthma supported by one or more other characteristics:
- bronchial provocation test positive;
- improvement in forced expiratory volume at one second (FEV1) of more than 12% and 200 mL after inhaled salbutamol;
- variability in diurnal peak expiratory flow (PEF) of more than 10% for one day during one week.
- bronchodilator and glucocorticoid treatment is effective;
- exclude the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, GERD, neuromuscular disease, and mental disease.
Exclusion Criteria:
- can not cooperate with related inspection or for other reasons;
- patients with chronic obstructive pulmonary disease, interstitial pneumonia, active tuberculosis, community acquired pneumonia, lung cancer, bronchiectasis, cor pulmonale, pulmonary embolism, and accompanied with serious systematic disease (such as coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease, neuromuscular disease, etc);
- history of drug abuse, alcohol abuse or anesthesia or with a history of mental illness (schizophrenia, obsessive-compulsive disorder, depression) and against personality, motivation, suspicious, or other emotional or mental issues that may affect participation in the study;
- taking part in other drug clinical trial project, or drop out less than 3 months;
- during pregnancy, lactation women;
- obvious abnormal of High Resolution CT.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Asthma control questionnaire (ACQ)
大体时间：Change from Baseline ACQ score at 36 months
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Asthma control questionnaire (ACQ)
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Change from Baseline ACQ score at 36 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Forced expiratory volume in one second
大体时间：Change from Baseline ACQ score at 36 months
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Forced expiratory volume in one second
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Change from Baseline ACQ score at 36 months
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Airway responsiveness
大体时间：Change from Baseline ACQ score at 36 months
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Airway responsiveness
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Change from Baseline ACQ score at 36 months
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Peak expiratory flow
大体时间：Change from Baseline ACQ score at 36 months
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Peak expiratory flow
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Change from Baseline ACQ score at 36 months
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Asthma quality of life questionnaire
大体时间：Change from Baseline ACQ score at 36 months
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Asthma quality of life questionnaire
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Change from Baseline ACQ score at 36 months
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Acute asthma episode
大体时间：Change from Baseline ACQ score at 36 months
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Acute asthma episode
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Change from Baseline ACQ score at 36 months
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Numbers of emergency or hospitalization
大体时间：Change from Baseline ACQ score at 36 months
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Numbers of emergency or hospitalization
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Change from Baseline ACQ score at 36 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Huahao Shen、Second Affiliated Hospital, School of Medicine, Zhejiang University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年3月1日
初级完成 (实际的)
2019年12月12日
研究完成 (实际的)
2020年10月23日
研究注册日期
首次提交
2017年7月24日
首先提交符合 QC 标准的
2017年7月28日
首次发布 (实际的)
2017年8月2日
研究记录更新
最后更新发布 (实际的)
2020年10月27日
上次提交的符合 QC 标准的更新
2020年10月24日
最后验证
2020年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
生活质量的临床试验
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Swansea University完全的
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Yale-NUS College完全的
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Scripps Translational Science Institute完全的
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Peking Union Medical College Hospital尚未招聘