Clinical Characteristics and Treatment of Chest Tightness Variant Asthma

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: fugui Yan; Phone Number: 13757158676; Email: yfg0726@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • China-Japan Friendship Hospital
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Chao-Yang Hospital
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • Xinqiao Hospital，Third Military Medical University
  • Fujian
    • Fuzhou, Fujian, China
      • Recruiting
      • The Second Affiliated Hospital，Fujian Medical University
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Nanfang Hospital, Nanfang Medical University
    • Guangzhou, Guangdong, China
      • Recruiting
      • The First Affiliated Hospital,Guangzhou Medical University
      • Contact: Nanshan Zhong
    • Shenzhen, Guangdong, China
      • Recruiting
      • People's Hospital of Shenzhen
    • Zhanjiang, Guangdong, China
      • Recruiting
      • Affiliated Hospital,Zhanjiang Medical College
  • Guizhou
    • Guiyang, Guizhou, China
      • Recruiting
      • Guizhou Provincial People's Hospital
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Provincial People's Hospital
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • The Second Xiangya Hospital of Central South University
    • Changsha, Hunan, China
      • Recruiting
      • Xiangya Hospital of Central South University
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Jiangsu Province Hospital
  • Liaoning
    • Shenyang, Liaoning, China
      • Recruiting
      • The Central Hospital of Shenyang Military
    • Shenyang, Liaoning, China
      • Recruiting
      • The First Affiliated Hospital, China Medical University
  • Shaanxi
    • Xi'an, Shaanxi, China
      • Recruiting
      • Xijing Hospital
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Qilu Hospital, Shandong University
    • Jinan, Shandong, China
      • Recruiting
      • Shandong Provincal Hospital
    • Qingdao, Shandong, China
      • Recruiting
      • Qingdao Municipal Hospital
    • Weifang, Shandong, China
      • Recruiting
      • Weifang Asthma Hospital
    • Yantai, Shandong, China
      • Recruiting
      • Yantai liuhuanding Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Zhongshan Hospital, Fudan University
    • Shanghai, Shanghai, China
      • Recruiting
      • Changhai Hospital, Second Military Medical University
    • Shanghai, Shanghai, China
      • Recruiting
      • No.1 Hospital, Shanghai Jiaotong University
    • Shanghai, Shanghai, China
      • Recruiting
      • Ruijin Hospital, Shanghai Jiaotong University
    • Shanghai, Shanghai, China
      • Recruiting
      • Tongji Hospital, Tongji University
    • Shanghai, Shanghai, China
      • Recruiting
      • Xinhua Hospital, Shanghai Jiaotong University
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Hospital,Sichuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • Second Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: Fugui Yan; Email: yfg0726@163.com
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Sir Run Run Shaw hospital, College of Medicine，Zhejiang University
    • Huzhou, Zhejiang, China
      • Recruiting
      • Huzhou Central Hospital
    • Wenzhou, Zhejiang, China
      • Recruiting
      • The Second Affiliated Hospital,Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ICS/LABA plus Montelukast	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
ACTIVE_COMPARATOR: ICS/LABA only	Drug: Inhaled corticosteriod/long-acting beta-agonist only; Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma control questionnaire (ACQ)	Scores of asthma control questionnaire (ACQ)	Change from baseline intervention therapy at 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2020
• Primary Completion (ANTICIPATED): July 1, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: March 24, 2020
• First Submitted That Met QC Criteria: March 25, 2020
• First Posted (ACTUAL): March 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 10, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Hematologic Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Leukocyte Disorders; Asthma; Eosinophilia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Asthmatic Agents; Respiratory System Agents; Leukotriene Antagonists; Hormone Antagonists; Cytochrome P-450 CYP1A2 Inducers; Cytochrome P-450 Enzyme Inducers; Montelukast
• Other Study ID Numbers: CTVA-ZJU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No