Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma

NCT ID: NCT03237221

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

76 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-01

Study Completion Date

2020-10-23

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma Chest Syndrome Clinical Anxiety Clinical Depression Lung Function Quality of Life Eosinophilia Nitric Oxide Airway Responsiveness Induced Sputum

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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yanfugui

Vice Director,Respiratory and Critical Care Medicine,Clinical Vice Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Huahao Shen

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status

Xinqiao Hospital,Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status

The Second Affiliated Hospital,Fujian Medical University

Fuzhou, Fujian, China

Site Status

Nanfang Hospital, Nanfang Medical University

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital,Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status

People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Site Status

Affiliated Hospital,Zhanjiang Medical College

Zhanjiang, Guangdong, China

Site Status

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Site Status

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status

Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status

The Central Hospital of Shenyang Military

Shenyang, Liaoning, China

Site Status

The First Affiliated Hospital, China Medical University

Shenyang, Liaoning, China

Site Status

Xijing Hospital

Xi'an, Shaanxi, China

Site Status

Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status

Shandong Provincal Hospital

Jinan, Shandong, China

Site Status

Qingdao Municipal Hospital

Qingdao, Shandong, China

Site Status

Weifang Asthma Hospital

Weifang, Shandong, China

Site Status

Yantai liuhuanding Hospital

Yantai, Shandong, China

Site Status

Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, China

Site Status

No.1 Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status

Ruijin Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status

Tongji Hospital, Tongji University

Shanghai, Shanghai Municipality, China

Site Status

Xinhua Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

West China Hospital,Sichuan University

Chengdu, Sichuan, China

Site Status

Sir Run Run Shaw hospital, College of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

Site Status

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hanzhou, Zhejiang, China

Site Status

Huzhou Central Hospital

Huzhou, Zhejiang, China

Site Status

The Second Affiliated Hospital,Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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CTVA-China

Identifier Type: -

Identifier Source: org_study_id