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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03237221
Other study ID # CTVA-China
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2015
Est. completion date October 23, 2020

Study information

Verified date October 2020
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 76
Est. completion date October 23, 2020
Est. primary completion date December 12, 2019
Accepts healthy volunteers No
Gender All
Age group 14 Years to 80 Years
Eligibility Inclusion Criteria: 1. all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent; 2. the age of more than 14 and less 80 years old, gender and ethnicity are not limited; 3. the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough; 4. no wheezing; 5. 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. 6. bronchodilator and glucocorticoid treatment is effective; 7. exclude the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, GERD, neuromuscular disease, and mental disease. Exclusion Criteria: 1. can not cooperate with related inspection or for other reasons; 2. 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); 3. 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; 4. taking part in other drug clinical trial project, or drop out less than 3 months; 5. during pregnancy, lactation women; 6. obvious abnormal of High Resolution CT.

Study Design


Intervention

Drug:
Treat patient according to Global Initiative for Asthma (GINA) guideline
Treat patient according to Global Initiative for Asthma (GINA) guideline

Locations

Country Name City State
China Beijing Chao-Yang Hospital Beijing Beijing
China Beijing Tongren Hospital, Capital Medical University Beijing Beijing
China China-Japan Friendship Hospital Beijing Beijing
China The Second Xiangya Hospital of Central South University Changsha Hunan
China Xiangya Hospital of Central South University Changsha Hunan
China West China Hospital,Sichuan University Chengdu Sichuan
China Xinqiao Hospital,Third Military Medical University Chongqing Chongqing
China The Second Affiliated Hospital,Fujian Medical University Fuzhou Fujian
China Nanfang Hospital, Nanfang Medical University Guangzhou Guangdong
China The First Affiliated Hospital,Guangzhou Medical University Guangzhou Guangdong
China Guizhou Provincial People's Hospital Guiyang Guizhou
China Sir Run Run Shaw hospital, College of Medicine,Zhejiang University Hangzhou Zhejiang
China Second Affiliated Hospital, School of Medicine, Zhejiang University Hanzhou Zhejiang
China Huzhou Central Hospital Huzhou Zhejiang
China Qilu Hospital, Shandong University Jinan Shandong
China Shandong Provincal Hospital Jinan Shandong
China Jiangsu Province Hospital Nanjing Jiangsu
China Qingdao Municipal Hospital Qingdao Shandong
China Changhai Hospital, Second Military Medical University Shanghai Shanghai
China No.1 Hospital, Shanghai Jiaotong University Shanghai Shanghai
China Ruijin Hospital, Shanghai Jiaotong University Shanghai Shanghai
China Tongji Hospital, Tongji University Shanghai Shanghai
China Xinhua Hospital, Shanghai Jiaotong University Shanghai Shanghai
China Zhongshan Hospital, Fudan University Shanghai Shanghai
China The Central Hospital of Shenyang Military Shenyang Liaoning
China The First Affiliated Hospital, China Medical University Shenyang Liaoning
China People's Hospital of Shenzhen Shenzhen Guangdong
China Weifang Asthma Hospital Weifang Shandong
China The Second Affiliated Hospital,Wenzhou Medical University Wenzhou Zhejiang
China Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology Wuhan Hubei
China Xijing Hospital Xi'an Shaanxi
China Yantai liuhuanding Hospital Yantai Shandong
China Affiliated Hospital,Zhanjiang Medical College Zhanjiang Guangdong
China Henan Provincial People's Hospital Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Asthma control questionnaire (ACQ) Asthma control questionnaire (ACQ) Change from Baseline ACQ score at 36 months
Secondary Forced expiratory volume in one second Forced expiratory volume in one second Change from Baseline ACQ score at 36 months
Secondary Airway responsiveness Airway responsiveness Change from Baseline ACQ score at 36 months
Secondary Peak expiratory flow Peak expiratory flow Change from Baseline ACQ score at 36 months
Secondary Asthma quality of life questionnaire Asthma quality of life questionnaire Change from Baseline ACQ score at 36 months
Secondary Acute asthma episode Acute asthma episode Change from Baseline ACQ score at 36 months
Secondary Numbers of emergency or hospitalization Numbers of emergency or hospitalization Change from Baseline ACQ score at 36 months
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