Clinical trial NCT04322422: Clinical Characteristics and Treatment of Chest Tightness Variant Asthma
Official title: Clinical Characteristics and Treatment of Chest Tightness Variant Asthma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Chest Syndrome
Clinical Anxiety
Clinical Depression
Lung Function
Quality of Life
Eosinophilia
Nitric Oxide
Airway Responsiveness
Induced Sputum
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 300
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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, 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Asthma control questionnaire (ACQ)
timeFrame: Change from baseline intervention therapy at 3 months
Secondary outcomes:
measure: Forced expiratory volume in one second
timeFrame: Change from baseline intervention therapy at 3 months
measure: Airway responsiveness
timeFrame: Change from baseline intervention therapy at 3 months
measure: Peak expiratory flow
timeFrame: Change from baseline intervention therapy at 3 months
measure: Asthma quality of life questionnaire
timeFrame: Change from baseline intervention therapy at 3 months
measure: Acute asthma episode
timeFrame: Change from baseline intervention therapy at 3 months
measure: Numbers of emergency or hospitalization
timeFrame: Change from baseline intervention therapy at 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
state: Beijing
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Chongqing
country: China
facility: Xinqiao Hospital，Third Military Medical University
state: Chongqing
city: Fuzhou
country: China
facility: The Second Affiliated Hospital，Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital, Nanfang Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital,Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: People's Hospital of Shenzhen
state: Guangdong
city: Zhanjiang
country: China
facility: Affiliated Hospital,Zhanjiang Medical College
state: Guangdong
city: Guiyang
country: China
facility: Guizhou Provincial People's Hospital
state: Guizhou
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Shenyang
country: China
facility: The Central Hospital of Shenyang Military
state: Liaoning
city: Shenyang
country: China
facility: The First Affiliated Hospital, China Medical University
state: Liaoning
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
city: Jinan
country: China
facility: Shandong Provincal Hospital
state: Shandong
city: Qingdao
country: China
facility: Qingdao Municipal Hospital
state: Shandong
city: Weifang
country: China
facility: Weifang Asthma Hospital
state: Shandong
city: Yantai
country: China
facility: Yantai liuhuanding Hospital
state: Shandong
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
state: Shanghai
city: Shanghai
country: China
facility: No.1 Hospital, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Tongji Hospital, Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital, Shanghai Jiaotong University
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital，Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw hospital, College of Medicine，Zhejiang University
state: Zhejiang
city: Huzhou
country: China
facility: Huzhou Central Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: The Second Affiliated Hospital,Wenzhou Medical University
state: Zhejiang
Study officials:
References: