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Clinical Characteristics and Treatment of Chest Tightness Variant Asthma

Primary Purpose

Asthma, Chest Syndrome, Clinical Anxiety

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Inhaled corticosteriod/long-acting beta-agonist plus Montelukast
Inhaled corticosteriod/long-acting beta-agonist only
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

14 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Chao-Yang HospitalRecruiting
  • China-Japan Friendship HospitalRecruiting
  • Xinqiao Hospital,Third Military Medical UniversityRecruiting
  • The Second Affiliated Hospital,Fujian Medical UniversityRecruiting
  • Nanfang Hospital, Nanfang Medical UniversityRecruiting
  • The First Affiliated Hospital,Guangzhou Medical UniversityRecruiting
  • People's Hospital of ShenzhenRecruiting
  • Affiliated Hospital,Zhanjiang Medical CollegeRecruiting
  • Guizhou Provincial People's HospitalRecruiting
  • Henan Provincial People's HospitalRecruiting
  • Tongji Hospital,Tongji Medical College,Huazhong University of Science and TechnologyRecruiting
  • The Second Xiangya Hospital of Central South UniversityRecruiting
  • Xiangya Hospital of Central South UniversityRecruiting
  • Jiangsu Province HospitalRecruiting
  • The Central Hospital of Shenyang MilitaryRecruiting
  • The First Affiliated Hospital, China Medical UniversityRecruiting
  • Xijing HospitalRecruiting
  • Qilu Hospital, Shandong UniversityRecruiting
  • Shandong Provincal HospitalRecruiting
  • Qingdao Municipal HospitalRecruiting
  • Weifang Asthma HospitalRecruiting
  • Yantai liuhuanding HospitalRecruiting
  • Changhai Hospital, Second Military Medical UniversityRecruiting
  • No.1 Hospital, Shanghai Jiaotong UniversityRecruiting
  • Ruijin Hospital, Shanghai Jiaotong UniversityRecruiting
  • Tongji Hospital, Tongji UniversityRecruiting
  • Xinhua Hospital, Shanghai Jiaotong UniversityRecruiting
  • Zhongshan Hospital, Fudan UniversityRecruiting
  • West China Hospital,Sichuan UniversityRecruiting
  • Second Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting
  • Sir Run Run Shaw hospital, College of Medicine,Zhejiang UniversityRecruiting
  • Huzhou Central HospitalRecruiting
  • The Second Affiliated Hospital,Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ICS/LABA plus Montelukast

ICS/LABA only

Arm Description

Outcomes

Primary Outcome Measures

Asthma control questionnaire (ACQ)
Scores of asthma control questionnaire (ACQ)

Secondary Outcome Measures

Forced expiratory volume in one second
Value of forced expiratory volume in one second
Airway responsiveness
Value of airway responsiveness
Peak expiratory flow
Value of peak expiratory flow
Asthma quality of life questionnaire
Scores of asthma quality of life questionnaire
Acute asthma episode
Numbers of acute asthma episode
Numbers of emergency or hospitalization
Numbers of emergency or hospitalization

Full Information

First Posted
March 24, 2020
Last Updated
May 10, 2020
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04322422
Brief Title
Clinical Characteristics and Treatment of Chest Tightness Variant Asthma
Official Title
Clinical Characteristics and Treatment of Chest Tightness Variant Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Anticipated)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Chest Syndrome, Clinical Anxiety, Clinical Depression, Lung Function, Quality of Life, Eosinophilia, Nitric Oxide, Airway Responsiveness, Induced Sputum

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ICS/LABA plus Montelukast
Arm Type
Experimental
Arm Title
ICS/LABA only
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Inhaled corticosteriod/long-acting beta-agonist plus Montelukast
Intervention Description
Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma; Montelukast is benefitial for allergic disease
Intervention Type
Drug
Intervention Name(s)
Inhaled corticosteriod/long-acting beta-agonist only
Intervention Description
Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma
Primary Outcome Measure Information:
Title
Asthma control questionnaire (ACQ)
Description
Scores of asthma control questionnaire (ACQ)
Time Frame
Change from baseline intervention therapy at 3 months
Secondary Outcome Measure Information:
Title
Forced expiratory volume in one second
Description
Value of forced expiratory volume in one second
Time Frame
Change from baseline intervention therapy at 3 months
Title
Airway responsiveness
Description
Value of airway responsiveness
Time Frame
Change from baseline intervention therapy at 3 months
Title
Peak expiratory flow
Description
Value of peak expiratory flow
Time Frame
Change from baseline intervention therapy at 3 months
Title
Asthma quality of life questionnaire
Description
Scores of asthma quality of life questionnaire
Time Frame
Change from baseline intervention therapy at 3 months
Title
Acute asthma episode
Description
Numbers of acute asthma episode
Time Frame
Change from baseline intervention therapy at 3 months
Title
Numbers of emergency or hospitalization
Description
Numbers of emergency or hospitalization
Time Frame
Change from baseline intervention therapy at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
fugui Yan
Phone
13757158676
Email
yfg0726@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huahao Shen
Facility Information:
Facility Name
Beijing Chao-Yang Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
China-Japan Friendship Hospital
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Name
Xinqiao Hospital,Third Military Medical University
City
Chongqing
State/Province
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital,Fujian Medical University
City
Fuzhou
State/Province
Fujian
Country
China
Individual Site Status
Recruiting
Facility Name
Nanfang Hospital, Nanfang Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital,Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nanshan Zhong
Facility Name
People's Hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital,Zhanjiang Medical College
City
Zhanjiang
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Name
Guizhou Provincial People's Hospital
City
Guiyang
State/Province
Guizhou
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
Country
China
Individual Site Status
Recruiting
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Name
The Central Hospital of Shenyang Military
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
The First Affiliated Hospital, China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Individual Site Status
Recruiting
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
Country
China
Individual Site Status
Recruiting
Facility Name
Qilu Hospital, Shandong University
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Shandong Provincal Hospital
City
Jinan
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Qingdao Municipal Hospital
City
Qingdao
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Weifang Asthma Hospital
City
Weifang
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Yantai liuhuanding Hospital
City
Yantai
State/Province
Shandong
Country
China
Individual Site Status
Recruiting
Facility Name
Changhai Hospital, Second Military Medical University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
No.1 Hospital, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Ruijin Hospital, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Tongji Hospital, Tongji University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Xinhua Hospital, Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Name
West China Hospital,Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Name
Second Affiliated Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fugui Yan
Email
yfg0726@163.com
Facility Name
Sir Run Run Shaw hospital, College of Medicine,Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
Huzhou Central Hospital
City
Huzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Name
The Second Affiliated Hospital,Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Clinical Characteristics and Treatment of Chest Tightness Variant Asthma

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