- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04322422
Clinical Characteristics and Treatment of Chest Tightness Variant Asthma
May 10, 2020 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
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
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: fugui Yan
- Phone Number: 13757158676
- Email: yfg0726@163.com
Study Locations
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Beijing
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Beijing, Beijing, China
- Recruiting
- China-Japan Friendship Hospital
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Beijing, Beijing, China
- Recruiting
- Beijing Chao-Yang Hospital
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Chongqing
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Chongqing, Chongqing, China
- Recruiting
- Xinqiao Hospital,Third Military Medical University
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Fujian
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Fuzhou, Fujian, China
- Recruiting
- The Second Affiliated Hospital,Fujian Medical University
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Guangdong
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Guangzhou, Guangdong, China
- Recruiting
- Nanfang Hospital, Nanfang Medical University
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Guangzhou, Guangdong, China
- Recruiting
- The First Affiliated Hospital,Guangzhou Medical University
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Contact:
- Nanshan Zhong
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Shenzhen, Guangdong, China
- Recruiting
- People's Hospital of Shenzhen
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Zhanjiang, Guangdong, China
- Recruiting
- Affiliated Hospital,Zhanjiang Medical College
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Guizhou
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Guiyang, Guizhou, China
- Recruiting
- Guizhou Provincial People's Hospital
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Henan
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Zhengzhou, Henan, China
- Recruiting
- Henan Provincial People's Hospital
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Hubei
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Wuhan, Hubei, China
- Recruiting
- Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology
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Hunan
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Changsha, Hunan, China
- Recruiting
- The Second Xiangya Hospital of Central South University
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Changsha, Hunan, China
- Recruiting
- Xiangya Hospital of Central South University
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Jiangsu
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Nanjing, Jiangsu, China
- Recruiting
- Jiangsu Province Hospital
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Liaoning
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Shenyang, Liaoning, China
- Recruiting
- The Central Hospital of Shenyang Military
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Shenyang, Liaoning, China
- Recruiting
- The First Affiliated Hospital, China Medical University
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Shaanxi
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Xi'an, Shaanxi, China
- Recruiting
- Xijing Hospital
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Shandong
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Jinan, Shandong, China
- Recruiting
- Qilu Hospital, Shandong University
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Jinan, Shandong, China
- Recruiting
- Shandong Provincal Hospital
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Qingdao, Shandong, China
- Recruiting
- Qingdao Municipal Hospital
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Weifang, Shandong, China
- Recruiting
- Weifang Asthma Hospital
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Yantai, Shandong, China
- Recruiting
- Yantai liuhuanding Hospital
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Shanghai
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Shanghai, Shanghai, China
- Recruiting
- Zhongshan Hospital, Fudan University
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Shanghai, Shanghai, China
- Recruiting
- Changhai Hospital, Second Military Medical University
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Shanghai, Shanghai, China
- Recruiting
- No.1 Hospital, Shanghai Jiaotong University
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Shanghai, Shanghai, China
- Recruiting
- Ruijin Hospital, Shanghai Jiaotong University
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Shanghai, Shanghai, China
- Recruiting
- Tongji Hospital, Tongji University
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Shanghai, Shanghai, China
- Recruiting
- Xinhua Hospital, Shanghai Jiaotong University
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Sichuan
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Chengdu, Sichuan, China
- Recruiting
- West China Hospital,Sichuan University
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Recruiting
- Second Affiliated Hospital, School of Medicine, Zhejiang University
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Contact:
- Fugui Yan
- Email: yfg0726@163.com
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Hangzhou, Zhejiang, China
- Recruiting
- Sir Run Run Shaw hospital, College of Medicine,Zhejiang University
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Huzhou, Zhejiang, China
- Recruiting
- Huzhou Central Hospital
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Wenzhou, Zhejiang, China
- Recruiting
- The Second Affiliated Hospital,Wenzhou Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ICS/LABA 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
|
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)
Time Frame: Change from baseline intervention therapy at 3 months
|
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
Time Frame: Change from baseline intervention therapy at 3 months
|
Value of forced expiratory volume in one second
|
Change from baseline intervention therapy at 3 months
|
Airway responsiveness
Time Frame: Change from baseline intervention therapy at 3 months
|
Value of airway responsiveness
|
Change from baseline intervention therapy at 3 months
|
Peak expiratory flow
Time Frame: Change from baseline intervention therapy at 3 months
|
Value of peak expiratory flow
|
Change from baseline intervention therapy at 3 months
|
Asthma quality of life questionnaire
Time Frame: Change from baseline intervention therapy at 3 months
|
Scores of asthma quality of life questionnaire
|
Change from baseline intervention therapy at 3 months
|
Acute asthma episode
Time Frame: Change from baseline intervention therapy at 3 months
|
Numbers of acute asthma episode
|
Change from baseline intervention therapy at 3 months
|
Numbers of emergency or hospitalization
Time Frame: Change from baseline intervention therapy at 3 months
|
Numbers of emergency or hospitalization
|
Change from baseline intervention therapy at 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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