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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, investigators 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. However, there is lack of definite treatment strategy for CTVA. In order to further understand the clinical characteristics and treatment of patients with CTVA, investigators conducted a national multicenter randomized control trial(RCT) study that compares inhaled corticosteroid(ICS)/ long-acting beta2-agonist(LABA) + Montelukast with ICS/LABA. Finally, investigators plan to clarify whether ICS/LABA plus Montelukast is more appropriate treatment than only ICS/LABA in CTVA patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICS/LABA plus Montelukast | Experimental |
| |
| ICS/LABA only | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled corticosteriod/long-acting beta-agonist plus Montelukast | Drug | Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma; Montelukast is benefitial for allergic disease |
| Measure | Description | Time Frame |
|---|---|---|
| Asthma control questionnaire (ACQ) | Scores of asthma control questionnaire (ACQ) | Change from baseline intervention therapy at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in one second | Value of forced expiratory volume in one second | Change from baseline intervention therapy at 3 months |
| Airway responsiveness | Value of airway responsiveness |
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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:
bronchodilator and glucocorticoid treatment is effective;
exclude the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease(GERD), neuromuscular disease, and mental disease.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| fugui Yan | Contact | 13757158676 | yfg0726@163.com | |
| Huahao Shen | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital | Recruiting | Beijing | Beijing Municipality | China | ||
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| Inhaled corticosteriod/long-acting beta-agonist only | Drug | Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma |
|
| Change from baseline intervention therapy at 3 months |
| Peak expiratory flow | Value of peak expiratory flow | Change from baseline intervention therapy at 3 months |
| Asthma quality of life questionnaire | Scores of asthma quality of life questionnaire | Change from baseline intervention therapy at 3 months |
| Acute asthma episode | Numbers of acute asthma episode | Change from baseline intervention therapy at 3 months |
| Numbers of emergency or hospitalization | Numbers of emergency or hospitalization | Change from baseline intervention therapy at 3 months |
| China-Japan Friendship Hospital |
| Recruiting |
| Beijing |
| Beijing Municipality |
| China |
| Xinqiao Hospital,Third Military Medical University | Recruiting | Chongqing | Chongqing Municipality | China |
| The Second Affiliated Hospital,Fujian Medical University | Recruiting | Fuzhou | Fujian | China |
| Nanfang Hospital, Nanfang Medical University | Recruiting | Guangzhou | Guangdong | China |
| The First Affiliated Hospital,Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
|
| People's Hospital of Shenzhen | Recruiting | Shenzhen | Guangdong | China |
| Affiliated Hospital,Zhanjiang Medical College | Recruiting | Zhanjiang | Guangdong | China |
| Guizhou Provincial People's Hospital | Recruiting | Guiyang | Guizhou | China |
| Henan Provincial People's Hospital | Recruiting | Zhengzhou | Henan | China |
| Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
| Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | China |
| Jiangsu Province Hospital | Recruiting | Nanjing | Jiangsu | China |
| The Central Hospital of Shenyang Military | Recruiting | Shenyang | Liaoning | China |
| The First Affiliated Hospital, China Medical University | Recruiting | Shenyang | Liaoning | China |
| Xijing Hospital | Recruiting | Xi'an | Shaanxi | China |
| Qilu Hospital, Shandong University | Recruiting | Jinan | Shandong | China |
| Shandong Provincal Hospital | Recruiting | Jinan | Shandong | China |
| Qingdao Municipal Hospital | Recruiting | Qingdao | Shandong | China |
| Weifang Asthma Hospital | Recruiting | Weifang | Shandong | China |
| Yantai liuhuanding Hospital | Recruiting | Yantai | Shandong | China |
| Changhai Hospital, Second Military Medical University | Recruiting | Shanghai | Shanghai Municipality | China |
| No.1 Hospital, Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | China |
| Ruijin Hospital, Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | China |
| Tongji Hospital, Tongji University | Recruiting | Shanghai | Shanghai Municipality | China |
| Xinhua Hospital, Shanghai Jiaotong University | Recruiting | Shanghai | Shanghai Municipality | China |
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | China |
| West China Hospital,Sichuan University | Recruiting | Chengdu | Sichuan | China |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
|
| Sir Run Run Shaw hospital, College of Medicine,Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
| Huzhou Central Hospital | Recruiting | Huzhou | Zhejiang | China |
| The Second Affiliated Hospital,Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | China |
| ID | Term |
|---|---|
| D001249 | Asthma |
| D003865 | Depressive Disorder, Major |
| D004802 | Eosinophilia |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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