Clinical Characteristics and Treatment of Chest Tightness Variant Asthma

Not Applicable

• Conditions: Asthma; Chest Syndrome; Clinical Anxiety; Clinical Depression; Lung Function; Quality of Life; Eosinophilia; Nitric Oxide; Airway Responsiveness; Induced Sputum
• Interventions: Drug: Inhaled corticosteriod/long-acting beta-agonist plus Montelukast; Drug: Inhaled corticosteriod/long-acting beta-agonist only

• Registration Number: NCT04322422
• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-03-25
• Study First Posted: 2020-03-26
• Last Update Submitted: 2020-05-10
• Last Update Posted: 2020-05-12
• Study Start: 2020-06-01
• Primary Completion: 2022-07-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICS/LABA plus Montelukast	Inhaled corticosteriod/long-acting beta-agonist plus Montelukast	-
ICS/LABA only	Inhaled corticosteriod/long-acting beta-agonist only	-

Primary Outcome Measures

Name	Time	Method
Asthma control questionnaire (ACQ)	Change from baseline intervention therapy at 3 months	Scores of asthma control questionnaire (ACQ)

Secondary Outcome Measures

Name	Time	Method
Peak expiratory flow	Change from baseline intervention therapy at 3 months	Value of peak expiratory flow
Forced expiratory volume in one second	Change from baseline intervention therapy at 3 months	Value of forced expiratory volume in one second
Airway responsiveness	Change from baseline intervention therapy at 3 months	Value of airway responsiveness
Asthma quality of life questionnaire	Change from baseline intervention therapy at 3 months	Scores of asthma quality of life questionnaire
Acute asthma episode	Change from baseline intervention therapy at 3 months	Numbers of acute asthma episode
Numbers of emergency or hospitalization	Change from baseline intervention therapy at 3 months	Numbers of emergency or hospitalization

Trial Locations

Locations (33)

China-Japan Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Xinqiao Hospital，Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

Nanfang Hospital, Nanfang Medical University; 🇨🇳 Guangzhou, Guangdong, China

People's Hospital of Shenzhen; 🇨🇳 Shenzhen, Guangdong, China

The First Affiliated Hospital,Guangzhou Medical University; 🇨🇳 Guangzhou, Guangdong, China

Guizhou Provincial People's Hospital; 🇨🇳 Guiyang, Guizhou, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

The Second Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

The First Affiliated Hospital, China Medical University; 🇨🇳 Shenyang, Liaoning, China

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China

Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China

Shandong Provincal Hospital; 🇨🇳 Jinan, Shandong, China

Qingdao Municipal Hospital; 🇨🇳 Qingdao, Shandong, China

Yantai liuhuanding Hospital; 🇨🇳 Yantai, 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

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

Beijing Chao-Yang Hospital; 🇨🇳 Beijing, Beijing, China

The Second Affiliated Hospital，Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

Affiliated Hospital,Zhanjiang Medical College; 🇨🇳 Zhanjiang, Guangdong, China

Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

The Central Hospital of Shenyang Military; 🇨🇳 Shenyang, Liaoning, China

Weifang Asthma Hospital; 🇨🇳 Weifang, Shandong, China

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

West China Hospital，Sichuan University; 🇨🇳 Chengdu, Sichuan, China

The Second Affiliated Hospital,Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China