Asthma Clinical Trial
Official title:
Clinical Characteristics and Treatment of Chest Tightness Variant Asthma
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2022 |
Est. primary completion date | July 1, 2022 |
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, gastroesophageal reflux disease(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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Chao-Yang Hospital | 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 | Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang |
China | Sir Run Run Shaw hospital, College of Medicine,Zhejiang University | Hangzhou | 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 |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Asthma control questionnaire (ACQ) | Scores of asthma control questionnaire (ACQ) | Change from baseline intervention therapy at 3 months | |
Secondary | Forced expiratory volume in one second | Value of forced expiratory volume in one second | Change from baseline intervention therapy at 3 months | |
Secondary | Airway responsiveness | Value of airway responsiveness | Change from baseline intervention therapy at 3 months | |
Secondary | Peak expiratory flow | Value of peak expiratory flow | Change from baseline intervention therapy at 3 months | |
Secondary | Asthma quality of life questionnaire | Scores of asthma quality of life questionnaire | Change from baseline intervention therapy at 3 months | |
Secondary | Acute asthma episode | Numbers of acute asthma episode | Change from baseline intervention therapy at 3 months | |
Secondary | Numbers of emergency or hospitalization | Numbers of emergency or hospitalization | Change from baseline intervention therapy at 3 months |
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