Bronchial AsthmaNCT06373692
REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma)
An observational study of Bronchial Asthma, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to define the standard use of TCM treatment regimen as the TCM cohort group and the non-TCM cohort group of those who use conventional Western medicine treatment without the standard TCM treatment regimen through a multi-center, large-sample prospective cohort study design. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchial Asthma
- How many people
- 1,508 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are eligible for a diagnosis of bronchial asthma disease
Who may be able to join
- Patients who meet the diagnosis of bronchial asthma;
- Age 18~80 years old;
- Have not participated in other clinical studies within 1 month before enrollment;
- Voluntarily participate in the study and sign the informed consent form.
Who cannot join
- Patients with respiratory failure and mechanical ventilation during acute asthma exacerbation;
- Delirium, impaired consciousness, dementia, and various mental illnesses;
- Patients with other lung diseases such as COPD, lung abscess, cystic fibrosis, bronchiectasis, etc., and severe liver and kidney diseases;
- Patients with neuromuscular diseases that affect respiratory motor function and are unable to complete the six-minute walk test;
- Pregnant and lactating patients;
- Those who are participating in other clinical trials.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan
Hai-bin Yu, Ph.D, +86 13526671773, wwz1231125@163.com
About this study
The purpose of this study is to define the standard use of TCM treatment regimen as the TCM cohort group and the non-TCM cohort group of those who use conventional Western medicine treatment without the standard TCM treatment regimen through a multi-center, large-sample prospective cohort study design. To evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and to provide high-quality evidence for the promotion and application of TCM syndrome differentiation treatment in bronchial asthma.
Read the detailed description
Bronchial asthma is characterized by chronic inflammation of the airways, which is often recurrent, long-lasting and difficult to cure. Clinical studies have confirmed that the clinical symptoms and quality of life of asthma patients have been significantly improved after TCM intervention. However, most of the current clinical research methods on asthma are small-sample and RCT studies, resulting in insufficient demonstration of efficacy, and there is an urgent need to carry out multi-center, large-sample, high-quality real-world studies in order to obtain higher quality evidence-based medical evidence.
This is a multi-center, large-sample prospective cohort study, which will evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and provide high-quality evidence for the promotion and application of TCM syndrome differentiation therapy in bronchial asthma. The cohort study will enroll 1508 patients, and the standard use of TCM treatment regimen will be set as the TCM cohort group, and those who will use the conventional treatment of Western medicine but not the standard TCM treatment regimen will be the non-TCM cohort group. The asthma control rate was the main outcome index, and the asthma control questionnaire (ACQ), asthma quality of life score (AQLQ), clinical symptom and sign score, lung function, exhaled nitric oxide, induced sputum inflammation phenotype, glucocorticoid dose, and fast-acting β2 agonist dose were the secondary outcome indicators. Follow-up was conducted every 3 months for 1 year.
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial asthma, Asthma control rate, Number of acute attacks, Cohort studies
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medical cohort | The standardized use of TCM treatment regimen was regarded as an exposure factor, and the treatment methods of the enrolled patients were defined and grouped: patients who took medication continuously for more than 3 months per year, or who took medication intermittently for more than 6 months in the total time of the year, were in the exposure group. | |
| Non Traditional Chinese Medical cohort | Those who used conventional Western medicine treatment without using standardized Chinese medicine treatment regimen were in the non-exposure group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control rate
According to the composite indicators such as symptoms, medication and pulmonary function test results, the clinical control level of asthma was divided into complete control, partial control and uncontrolled, and the asthma control rate of patients was evaluated according to the clinical control level of asthma.
Measured: The follow-up period was followed up every 3 months for 1 year.
Secondary outcomes (12)
Number of exacerbations
The number of acute attacks is mainly recorded
Measured: The follow-up period was followed up every 3 months for 1 year.
Asthma exacerbation severity
Worsening lung function during asthma attacks is characterized by decreased expiratory flow, and the severity of the exacerbation can be graded by the patient's symptoms, lung function, and arterial blood gas analysis.According to the frequency of daytime and nighttime asthma attacks and pulmonary function test results, the patients were divided into 4 grades, namely: 1 intermittent attack; 2 mild persistent; 3 moderate persistent and 4 severe persistent.The severity of the asthma attack was assessed using a rating scale.
Measured: The follow-up period was followed up every 3 months for 1 year.
Change in severity of chronic persistent disease
Although the patient does not have an acute attack of asthma, there are still symptoms such as wheezing, cough, chest tightness and other symptoms with different frequency and degrees for a long time, which may be accompanied by decreased pulmonary ventilation function. The severity of chronic persistent asthma can be classified into four levels: intermittent, mildly persistent, moderately persistent, and severely persistent, according to the frequency of daytime and nighttime asthma symptoms and the results of pulmonary function tests.The severity of the asthma attack was assessed using a rating scale.
Measured: The follow-up period was followed up every 3 months for 1 year.
The dose used by glucocorticoids
Corticosteroids are the drug of choice for long-term asthma treatment. The vast majority of patients with chronic persistent asthma are well controlled by inhaling low-dose corticosteroids (equivalent to 400 micrograms of budesonide per day).
Measured: The follow-up period was followed up every 3 months for 1 year.
Rapid-acting beta2 agonists use drugs and doses
Beta2 agonists are asthma drugs that stimulate beta2 receptors distributed on airway smooth muscle to produce bronchodilating effects. These drugs are bronchodilators and are the drugs of choice for acute asthma attacks (airway spasm), which can quickly improve symptoms such as dyspnea, cough, etc. If given by inhalation, salbutamol 100-200mcg or terbutaline 250-500mcg at a time and repeat every 20 minutes if necessary.
Measured: The follow-up period was followed up every 3 months for 1 year.
Asthma Control Test (ACT) score
The ACT score correlates well with the level of asthma control in patients as assessed by experts. The questionnaire included wheezing symptoms, activity limitations, frequency of use of rescue medication, patients' asthma control and self-assessment, with a total of 5 items. Each item is scored on a scale of 1~5, with a total score of 5~25 points, and the higher the score, the better the control of asthma symptoms.
Measured: The follow-up period was followed up every 3 months for 1 year.
Asthma Control Questionnaire (ACQ)
The ACQ questionnaire will measure the quality of life associated with asthma. The ACQ questionnaire consists of either 7 questions (ACQ-7) or 6 questions (ACQ-6). In questions 1-6, patients recalled their experiences from the previous 7 days and answered using a scale of 7 (from 0 = complete control to 6 = very poor control). The seventh question refers to % FEV1 of the reference value and must be completed by the staff of the website. The questionnaire score is the average of either 7 responses (ACQ-7) or 6 responses (ACQ-6). The score is interpreted as follows: 0.75 or less: adequate asthma control. From 0.75 to 1.50: partially controlled asthma. Over 1.50: inadequate asthma control.
Measured: The follow-up period was followed up every 3 months for 1 year.
Asthma Quality of Life Score (AQLQ)
It is used to measure the severity of asthma and its impact on patients' quality of life, including 35 items in 5 aspects. The AQLQ score relates to activity limitation, asthma symptoms, psychological condition, response to stimuli, and concern for one's own health, and the form assesses the degree of impact of asthma on a 7-point scale, with a maximum impact of 1 point and no impact of 7 points.
Measured: The follow-up period was followed up every 3 months for 1 year.
Anxiety Self-Assessment Form (SAS)
It included 20 items reflecting the subjective feelings of anxiety, and each item was divided into four levels according to the frequency of symptoms, including 15 positive scores and 5 reverse scores. The cut-off value for the standard deviation of SAS is 50 points, with higher scores indicating more severe symptoms of anxiety.Among them, 50 to 59 are classified as mild anxiety, 60 to 69 are classified as moderate anxiety, and more than 69 are severe anxiety.
Measured: The follow-up period was followed up every 3 months for 1 year.
Depression Self-Rating Scale (SDS)
The SDS Depression and Anxiety Test Form contains 20 items, which are scored on a 4-point scale, with 1 indicating occasional symptoms, 2 indicating sometimes symptoms, 3 indicating frequent symptoms, and 4 indicating persistent symptoms. A rough score is obtained by adding the scores in each of the 20 items. Multiply the rough score by 1.25 and then take the integer part to get the standard score. Generally speaking, depression with a total score of less than 52 is normal, 53-62 is mild depression, 63-72 is moderate depression, and 72 or more is severe depression. The higher the score, the more severe the symptoms.
Measured: The follow-up period was followed up every 3 months for 1 year.
Pulmonary function
FVC, FEV1, FEV1 % of the estimated value, FEV1/FVC were mainly used for evaluation.
Measured: The follow-up period was followed up every 3 months for 1 year.
Exhaled nitric oxide (FeNO)
The measuring instrument uses an exhaled nitric oxide measurement system to record the FeNO value of the patient.
Measured: The follow-up period was followed up every 3 months for 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Third Affiliated Hospital of Henan University of Traditional Chinese Medicine, Hebei Provincial Hospital of Traditional Chinese Medicine, Peking University People's Hospital, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, The First Affiliated Hospital of Zhengzhou University, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Jian-sheng Li, Professor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373692
- Sponsor's protocol ID
- TCM for Asthma Cohort
- Status last verified
- Apr 2024
- First submitted
- 3 Jan 2024
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REspiratory diSEAse cohoRt Studies of CHinese Medicine for Asthma (RESEARCH- Asthma)
- ClinicalTrials.gov ID
- NCT06373692
- Acronym / sponsor ID
- TCM for Asthma Cohort
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial asthma, Asthma control rate, Number of acute attacks, Cohort studies
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,508 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Third Affiliated Hospital of Henan University of Traditional Chinese Medicine, Hebei Provincial Hospital of Traditional Chinese Medicine, Peking University People's Hospital, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, The First Affiliated Hospital of Zhengzhou University, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Apr 2024 (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.
The purpose of this study is to define the standard use of TCM treatment regimen as the TCM cohort group and the non-TCM cohort group of those who use conventional Western medicine treatment without the standard TCM treatment regimen through a multi-center, large-sample prospective cohort study design. To evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and to provide high-quality evidence for the promotion and application of TCM syndrome differentiation treatment in bronchial asthma.
Detailed description
Bronchial asthma is characterized by chronic inflammation of the airways, which is often recurrent, long-lasting and difficult to cure. Clinical studies have confirmed that the clinical symptoms and quality of life of asthma patients have been significantly improved after TCM intervention. However, most of the current clinical research methods on asthma are small-sample and RCT studies, resulting in insufficient demonstration of efficacy, and there is an urgent need to carry out multi-center, large-sample, high-quality real-world studies in order to obtain higher quality evidence-based medical evidence.
This is a multi-center, large-sample prospective cohort study, which will evaluate the clinical efficacy and safety of TCM treatment regimens in the treatment of bronchial asthma, and provide high-quality evidence for the promotion and application of TCM syndrome differentiation therapy in bronchial asthma. The cohort study will enroll 1508 patients, and the standard use of TCM treatment regimen will be set as the TCM cohort group, and those who will use the conventional treatment of Western medicine but not the standard TCM treatment regimen will be the non-TCM cohort group. The asthma control rate was the main outcome index, and the asthma control questionnaire (ACQ), asthma quality of life score (AQLQ), clinical symptom and sign score, lung function, exhaled nitric oxide, induced sputum inflammation phenotype, glucocorticoid dose, and fast-acting β2 agonist dose were the secondary outcome indicators. Follow-up was conducted every 3 months for 1 year.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medical cohort | – | –The standardized use of TCM treatment regimen was regarded as an exposure factor, and the treatment methods of the enrolled patients were defined and grouped: patients who took medication continuously for more than 3 months per year, or who took medication intermittently for more than 6 months in the total time of the year, were in the exposure group. |
| Non Traditional Chinese Medical cohort | – | –Those who used conventional Western medicine treatment without using standardized Chinese medicine treatment regimen were in the non-exposure group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are eligible for a diagnosis of bronchial asthma disease
Key inclusion criteria (4 listed)
- Patients who meet the diagnosis of bronchial asthma;
- Age 18~80 years old;
- Have not participated in other clinical studies within 1 month before enrollment;
- Voluntarily participate in the study and sign the informed consent form.
Key exclusion criteria (6 listed)
- Patients with respiratory failure and mechanical ventilation during acute asthma exacerbation;
- Delirium, impaired consciousness, dementia, and various mental illnesses;
- Patients with other lung diseases such as COPD, lung abscess, cystic fibrosis, bronchiectasis, etc., and severe liver and kidney diseases;
- Patients with neuromuscular diseases that affect respiratory motor function and are unable to complete the six-minute walk test;
- Pregnant and lactating patients;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Asthma control rate
Time frame: The follow-up period was followed up every 3 months for 1 year.
According to the composite indicators such as symptoms, medication and pulmonary function test results, the clinical control level of asthma was divided into complete control, partial control and uncontrolled, and the asthma control rate of patients was evaluated according to the clinical control level of asthma.
12 secondary outcomes
Number of exacerbations
Time frame: The follow-up period was followed up every 3 months for 1 year.
Asthma exacerbation severity
Time frame: The follow-up period was followed up every 3 months for 1 year.
Change in severity of chronic persistent disease
Time frame: The follow-up period was followed up every 3 months for 1 year.
The dose used by glucocorticoids
Time frame: The follow-up period was followed up every 3 months for 1 year.
Rapid-acting beta2 agonists use drugs and doses
Time frame: The follow-up period was followed up every 3 months for 1 year.
Asthma Control Test (ACT) score
Time frame: The follow-up period was followed up every 3 months for 1 year.
Asthma Control Questionnaire (ACQ)
Time frame: The follow-up period was followed up every 3 months for 1 year.
Asthma Quality of Life Score (AQLQ)
Time frame: The follow-up period was followed up every 3 months for 1 year.
Anxiety Self-Assessment Form (SAS)
Time frame: The follow-up period was followed up every 3 months for 1 year.
Depression Self-Rating Scale (SDS)
Time frame: The follow-up period was followed up every 3 months for 1 year.
Pulmonary function
Time frame: The follow-up period was followed up every 3 months for 1 year.
Exhaled nitric oxide (FeNO)
Time frame: The follow-up period was followed up every 3 months for 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Jian-sheng Li, Professor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by Henan University of Traditional Chinese Medicine at 1 site 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 4 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: opening soon, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hai-bin Yu, Ph.D (+86 13526671773, wwz1231125@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control rate (time frame: The follow-up period was followed up every 3 months for 1 year.). 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 18 Apr 2024.