AsthmaNCT03237221
Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma
An observational study of Asthma and Chest Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 34 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?
- Treat patient according to Global Initiative for Asthma (GINA) guideline
- How many people
- 76 participants
- Where
- 34 sitesChina
- Study dates
- 1 Mar 2015to 23 Oct 2020
- Phase
- Observational
- 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
Study population: Patients with only symptom of chest tightness and bronchial provocation test positive according to eligibility criteria.
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, 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
34 sites in 1 country.
34 sites in 1 country
China34 sites
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality
China-Japan Friendship Hospital
Beijing, Beijing Municipality
The Second Xiangya Hospital of Central South University
Changsha, Hunan
Xiangya Hospital of Central South University
Changsha, Hunan
West China Hospital，Sichuan University
Chengdu, Sichuan
Xinqiao Hospital，Third Military Medical University
Chongqing, Chongqing Municipality
The Second Affiliated Hospital，Fujian Medical University
Fuzhou, Fujian
Nanfang Hospital, Nanfang Medical University
Guangzhou, Guangdong
The First Affiliated Hospital,Guangzhou Medical University
Guangzhou, Guangdong
Guizhou Provincial People's Hospital
Guiyang, Guizhou
Sir Run Run Shaw hospital, College of Medicine，Zhejiang University
Hangzhou, Zhejiang
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hanzhou, Zhejiang, 310000
Huzhou Central Hospital
Huzhou, Zhejiang
Qilu Hospital, Shandong University
Jinan, Shandong
Shandong Provincal Hospital
Jinan, Shandong
Jiangsu Province Hospital
Nanjing, Jiangsu
Qingdao Municipal Hospital
Qingdao, Shandong
Changhai Hospital, Second Military Medical University
Shanghai, Shanghai Municipality
No.1 Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality
Ruijin Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality
Tongji Hospital, Tongji University
Shanghai, Shanghai Municipality
Xinhua Hospital, Shanghai Jiaotong University
Shanghai, Shanghai Municipality
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality
The Central Hospital of Shenyang Military
Shenyang, Liaoning
The First Affiliated Hospital, China Medical University
Shenyang, Liaoning
People's Hospital of Shenzhen
Shenzhen, Guangdong
Weifang Asthma Hospital
Weifang, Shandong
The Second Affiliated Hospital,Wenzhou Medical University
Wenzhou, Zhejiang
Tongji Hospital，Tongji Medical College，Huazhong University of Science and Technology
Wuhan, Hubei
Xijing Hospital
Xi'an, Shaanxi
Yantai liuhuanding Hospital
Yantai, Shandong
Affiliated Hospital,Zhanjiang Medical College
Zhanjiang, Guangdong
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, we 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. In order to further understand the clinical characteristics, pathogenesis, and prognosis of patients with CTVA, we conducted a national multicenter observation study to further understand CTVA. Finally, we plan to clarify whether CTVA is a relatively independent asthma phenotype. Meanwhile, reducing misdiagnosis and perform an appropriate treatment of CTVA.
- Conditions
- Asthma, Chest Syndrome, Clinical Anxiety, Clinical Depression, Lung Function, Quality of Life
- Being tested
- Treat patient according to Global Initiative for Asthma (GINA) guideline
- 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.
Treat patient according to Global Initiative for Asthma (GINA) guidelineDrug
Treat patient according to Global Initiative for Asthma (GINA) guideline
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control questionnaire (ACQ)
Asthma control questionnaire (ACQ)
Measured: Change from Baseline ACQ score at 36 months
Secondary outcomes (6)
Forced expiratory volume in one second
Forced expiratory volume in one second
Measured: Change from Baseline ACQ score at 36 months
Airway responsiveness
Airway responsiveness
Measured: Change from Baseline ACQ score at 36 months
Peak expiratory flow
Peak expiratory flow
Measured: Change from Baseline ACQ score at 36 months
Asthma quality of life questionnaire
Asthma quality of life questionnaire
Measured: Change from Baseline ACQ score at 36 months
Acute asthma episode
Acute asthma episode
Measured: Change from Baseline ACQ score at 36 months
Numbers of emergency or hospitalization
Numbers of emergency or hospitalization
Measured: Change from Baseline ACQ score at 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2017
- Study start1 Mar 2015
- Primary completion12 Dec 2019
- Study completion23 Oct 2020
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yanfugui, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- Huahao Shen, Study chair, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03237221
- Sponsor's protocol ID
- CTVA-China
- Status last verified
- Oct 2020
- First submitted
- 24 Jul 2017
- Last updated
- 27 Oct 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 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma
- ClinicalTrials.gov ID
- NCT03237221
- Acronym / sponsor ID
- CTVA-China
- Conditions
- Asthma, Chest Syndrome, Clinical Anxiety, Clinical Depression, Lung Function, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 12 Dec 2019 (actual)
- Study completion
- 23 Oct 2020 (actual)
- First posted
- 2 Aug 2017 (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, we 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. In order to further understand the clinical characteristics, pathogenesis, and prognosis of patients with CTVA, we conducted a national multicenter observation study to further understand CTVA. Finally, we plan to clarify whether CTVA is a relatively independent asthma phenotype. Meanwhile, reducing misdiagnosis and perform an appropriate treatment of CTVA.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with only symptom of chest tightness and bronchial provocation test positive according to eligibility criteria.
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 |
|---|---|---|
| Treat patient according to Global Initiative for Asthma (GINA) guidelineTreat patient according to Global Initiative for Asthma (GINA) guideline | Drug | – |
Primary outcome
Asthma control questionnaire (ACQ)
Time frame: Change from Baseline ACQ score at 36 months
Asthma control questionnaire (ACQ)
6 secondary outcomes
Forced expiratory volume in one second
Time frame: Change from Baseline ACQ score at 36 months
Airway responsiveness
Time frame: Change from Baseline ACQ score at 36 months
Peak expiratory flow
Time frame: Change from Baseline ACQ score at 36 months
Asthma quality of life questionnaire
Time frame: Change from Baseline ACQ score at 36 months
Acute asthma episode
Time frame: Change from Baseline ACQ score at 36 months
Numbers of emergency or hospitalization
Time frame: Change from Baseline ACQ score at 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 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 study chair
Second Affiliated Hospital, Zhejiang University, School of Medicine
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Chest Syndrome, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 34 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: finished, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control questionnaire (ACQ) (time frame: Change from Baseline ACQ score at 36 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 27 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.