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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

300

participants targeted

Target at P75+ for not_applicable asthma

Timeline

Completed

Started Jun 2020

Typical duration for not_applicable asthma

Geographic Reach

1 country

33 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

First Submitted

Initial submission to the registry

March 24, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2020

Completed

2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed

Last Updated

May 12, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

March 24, 2020

Last Update Submit

May 10, 2020

Conditions

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

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

Forced expiratory volume in one second
Change from baseline intervention therapy at 3 months
Airway responsiveness
Change from baseline intervention therapy at 3 months
Peak expiratory flow
Change from baseline intervention therapy at 3 months
Asthma quality of life questionnaire
Change from baseline intervention therapy at 3 months
Acute asthma episode
Change from baseline intervention therapy at 3 months
+1 more secondary outcomes

Study Arms (2)

ICS/LABA plus Montelukast

EXPERIMENTAL

Drug: Inhaled corticosteriod/long-acting beta-agonist plus Montelukast

ICS/LABA only

ACTIVE COMPARATOR

Drug: Inhaled corticosteriod/long-acting beta-agonist only

Interventions

Inhaled corticosteriod/long-acting beta-agonist plus MontelukastDRUG

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

ICS/LABA plus Montelukast

Inhaled corticosteriod/long-acting beta-agonist onlyDRUG

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

ICS/LABA only

Eligibility Criteria

Age14 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent;
the age of more than 14 and less 80 years old, gender and ethnicity are not limited;
the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough;
no wheezing;
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.
bronchodilator and glucocorticoid treatment is effective;
exclude the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease(GERD), neuromuscular disease, and mental disease.

You may not qualify if:

can not cooperate with related inspection or for other reasons;
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);
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;
taking part in other drug clinical trial project, or drop out less than 3 months;
during pregnancy, lactation women;
obvious abnormal of High Resolution CT.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang Universitylead

Study Sites (33)

Beijing Chao-Yang Hospital

Beijing, Beijing Municipality, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

RECRUITING

Xinqiao Hospital，Third Military Medical University

Chongqing, Chongqing Municipality, China

RECRUITING

The Second Affiliated Hospital，Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

Nanfang Hospital, Nanfang Medical University

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital,Guangzhou Medical University

Guangzhou, Guangdong, China

RECRUITING

People's Hospital of Shenzhen

Shenzhen, Guangdong, China

RECRUITING

Affiliated Hospital,Zhanjiang Medical College

Zhanjiang, Guangdong, China

RECRUITING

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

RECRUITING

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

Wuhan, Hubei, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Jiangsu Province Hospital

Nanjing, Jiangsu, China

RECRUITING

The Central Hospital of Shenyang Military

Shenyang, Liaoning, China

RECRUITING

The First Affiliated Hospital, China Medical University

Shenyang, Liaoning, China

RECRUITING

Xijing Hospital

Xi'an, Shaanxi, China

RECRUITING

Qilu Hospital, Shandong University

Jinan, Shandong, China

RECRUITING

Shandong Provincal Hospital

Jinan, Shandong, China

RECRUITING

Qingdao Municipal Hospital

Qingdao, Shandong, China

RECRUITING

Weifang Asthma Hospital

Weifang, Shandong, China

RECRUITING

Yantai liuhuanding Hospital

Yantai, Shandong, China

RECRUITING

Changhai Hospital, Second Military Medical University