Clinical Characteristics and Treatment of Chest Tightness Variant Asthma

NCT ID: NCT04322422

Last Updated: 2020-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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ICS/LABA plus Montelukast

Group Type EXPERIMENTAL

Inhaled corticosteriod/long-acting beta-agonist plus Montelukast

Intervention Type DRUG

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

ICS/LABA only

Group Type ACTIVE_COMPARATOR

Inhaled corticosteriod/long-acting beta-agonist only

Intervention Type DRUG

Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma

Interventions

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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

Intervention Type DRUG

Inhaled corticosteriod/long-acting beta-agonist only

Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Xinqiao Hospital,Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

The Second Affiliated Hospital,Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Nanfang Hospital, Nanfang Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

The First Affiliated Hospital,Guangzhou Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Site Status RECRUITING

Affiliated Hospital,Zhanjiang Medical College

Zhanjiang, Guangdong, China

Site Status RECRUITING

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Site Status RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Site Status RECRUITING

Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

Site Status RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

The Central Hospital of Shenyang Military

Shenyang, Liaoning, China

Site Status RECRUITING

The First Affiliated Hospital, China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Xijing Hospital

Xi'an, Shaanxi, China

Site Status RECRUITING

Qilu Hospital, Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Shandong Provincal Hospital

Jinan, Shandong, China

Site Status RECRUITING

Qingdao Municipal Hospital

Qingdao, Shandong, China

Site Status RECRUITING

Weifang Asthma Hospital

Weifang, Shandong, China

Site Status RECRUITING

Yantai liuhuanding Hospital

Yantai, Shandong, China

Site Status RECRUITING

Changhai Hospital, Second Military Medical University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

No.1 Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Ruijin Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Tongji Hospital, Tongji University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Xinhua Hospital, Shanghai Jiaotong University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

West China Hospital,Sichuan University

Chengdu, Sichuan, China

Site Status RECRUITING

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Sir Run Run Shaw hospital, College of Medicine,Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Huzhou Central Hospital

Huzhou, Zhejiang, China

Site Status RECRUITING

The Second Affiliated Hospital,Wenzhou Medical University

Wenzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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fugui Yan

Role: CONTACT

13757158676

Huahao Shen

Role: CONTACT

Facility Contacts

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Nanshan Zhong

Role: primary

Fugui Yan

Role: primary

Other Identifiers

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CTVA-ZJU

Identifier Type: -

Identifier Source: org_study_id

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