AsthmaNCT04322422
Clinical Characteristics and Treatment of Chest Tightness Variant Asthma
A study testing Inhaled corticosteriod/long-acting beta-agonist plus Montelukast and Inhaled corticosteriod/long-acting beta-agonist only in people with Asthma and Chest Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 33 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Asthma, Chest Syndrome, Clinical Anxiety
- What is being tested?
- Inhaled corticosteriod/long-acting beta-agonist plus Montelukast and Inhaled corticosteriod/long-acting beta-agonist only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 33 sitesChina
- Study dates
- 1 Jun 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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.
Trial locations and contacts
33 sites in 1 country.
Huahao Shen contact
33 sites in 1 country
China33 sites, 33 recruiting
- Recruiting
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality
- Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
- Recruiting
West China Hospital，Sichuan University
Chengdu, Sichuan
- Recruiting
Xinqiao Hospital，Third Military Medical University
Chongqing, Chongqing Municipality
- Recruiting
The Second Affiliated Hospital，Fujian Medical University
Fuzhou, Fujian
- Recruiting
Nanfang Hospital, Nanfang Medical University
Guangzhou, Guangdong
- Recruiting
The First Affiliated Hospital,Guangzhou Medical University
Guangzhou, Guangdong
Nanshan Zhong
- Recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Fugui Yan, yfg0726@163.com
- Recruiting
Sir Run Run Shaw hospital, College of Medicine，Zhejiang University
Hangzhou, Zhejiang
- Recruiting
Huzhou Central Hospital
Huzhou, Zhejiang
- Recruiting
Qilu Hospital, Shandong University
Jinan, Shandong
- Recruiting
Shandong Provincal Hospital
Jinan, Shandong
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
- Recruiting
Qingdao Municipal Hospital
Qingdao, Shandong
- Recruiting
Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality
- Recruiting
No.1 Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality
- Recruiting
Tongji Hospital, Tongji University
Shanghai, Shanghai Municipality
- Recruiting
Xinhua Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
- Recruiting
The Central Hospital of Shenyang Military
Shenyang, Liaoning
- Recruiting
The First Affiliated Hospital, China Medical University
Shenyang, Liaoning
- Recruiting
People's Hospital of Shenzhen
Shenzhen, Guangdong
- Recruiting
Weifang Asthma Hospital
Weifang, Shandong
- Recruiting
The Second Affiliated Hospital,Wenzhou Medical University
Wenzhou, Zhejiang
- Recruiting
Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology
Wuhan, Hubei
- Recruiting
Xijing Hospital
Xi'an, Shaanxi
- Recruiting
Yantai liuhuanding Hospital
Yantai, Shandong
- Recruiting
Affiliated Hospital,Zhanjiang Medical College
Zhanjiang, Guangdong
- Recruiting
Henan Provincial People's Hospital
Zhengzhou, Henan
About this study
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.
- Conditions
- Asthma, Chest Syndrome, Clinical Anxiety, Clinical Depression, Lung Function, Quality of Life
- Being tested
- Inhaled corticosteriod/long-acting beta-agonist plus Montelukast, Inhaled corticosteriod/long-acting beta-agonist only
- Medical subject headings
- Asthma, Depressive Disorder, Major, Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Inhaled corticosteriod/long-acting beta-agonist onlyDrug
Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma
| Study group | Role | What they receive |
|---|---|---|
| ICS/LABA plus Montelukast | Experimental | Not described Receives: Drug: Inhaled corticosteriod/long-acting beta-agonist plus Montelukast |
| ICS/LABA only | Active comparator | Not described Receives: Drug: Inhaled corticosteriod/long-acting beta-agonist only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control questionnaire (ACQ)
Scores of asthma control questionnaire (ACQ)
Measured: Change from baseline intervention therapy at 3 months
Secondary outcomes (6)
Forced expiratory volume in one second
Value of forced expiratory volume in one second
Measured: Change from baseline intervention therapy at 3 months
Airway responsiveness
Value of airway responsiveness
Measured: Change from baseline intervention therapy at 3 months
Peak expiratory flow
Value of peak expiratory flow
Measured: Change from baseline intervention therapy at 3 months
Asthma quality of life questionnaire
Scores of asthma quality of life questionnaire
Measured: Change from baseline intervention therapy at 3 months
Acute asthma episode
Numbers of acute asthma episode
Measured: Change from baseline intervention therapy at 3 months
Numbers of emergency or hospitalization
Numbers of emergency or hospitalization
Measured: Change from baseline intervention therapy at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322422
- Sponsor's protocol ID
- CTVA-ZJU
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2020
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Treatment of Chest Tightness Variant Asthma
- ClinicalTrials.gov ID
- NCT04322422
- Acronym / sponsor ID
- CTVA-ZJU
- Conditions
- Asthma, Chest Syndrome, Clinical Anxiety, Clinical Depression, Lung Function, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled corticosteriod/long-acting beta-agonist plus MontelukastInhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma; Montelukast is benefitial for allergic disease | Drug | ICS/LABA plus Montelukast |
| Inhaled corticosteriod/long-acting beta-agonist onlyInhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma | Drug | ICS/LABA only |
Primary outcome
Asthma control questionnaire (ACQ)
Time frame: Change from baseline intervention therapy at 3 months
Scores of asthma control questionnaire (ACQ)
6 secondary outcomes
Forced expiratory volume in one second
Time frame: Change from baseline intervention therapy at 3 months
Airway responsiveness
Time frame: Change from baseline intervention therapy at 3 months
Peak expiratory flow
Time frame: Change from baseline intervention therapy at 3 months
Asthma quality of life questionnaire
Time frame: Change from baseline intervention therapy at 3 months
Acute asthma episode
Time frame: Change from baseline intervention therapy at 3 months
Numbers of emergency or hospitalization
Time frame: Change from baseline intervention therapy at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huahao Shen contact
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaled corticosteriod/long-acting beta-agonist plus Montelukast and Inhaled corticosteriod/long-acting beta-agonist only in people with Asthma and Chest Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 33 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact fugui Yan (13757158676, yfg0726@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control questionnaire (ACQ) (time frame: Change from baseline intervention therapy at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.