Clinical Characteristics and Treatment of Chest Tightness Variant Asthma

Asthma Clinical Trial

Official title:

Clinical Characteristics and Treatment of Chest Tightness Variant Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04322422
• Other study ID #: CTVA-ZJU
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: March 2020
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: fugui Yan
• Phone: 13757158676
• Email: yfg0726[@]163.com
• Is FDA regulated: No
• Study type: Interventional

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, 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Inhaled corticosteriod/long-acting beta-agonist plus Montelukast
Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma; Montelukast is benefitial for allergic disease
• Inhaled corticosteriod/long-acting beta-agonist only
Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma

Locations

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

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)	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