Chronic Obstructive Pulmoriary Disease (COPD)NCT06577701
Respiratory Disease Cohort Studies of Chinese Medicine for COPD(RESEARCH-COPD)
An observational study of Chronic Obstructive Pulmoriary Disease (COPD) and Preserved Ratio Impaired Spirometry (PRISM), run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study will establish a registration research platform, a clinical research database and a biospecimen bank for the prevention and treatment of COPD with Chinese medicine. Based on the COPD registry database, a cohort of Chinese medicine for COPD prevention and treatment will be established. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmoriary Disease (COPD), Preserved Ratio Impaired Spirometry (PRISM)
- What is being tested?
- traditional Chinese medicine (TCM) and non traditional Chinese medicine (non-TCM)
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2024to 30 Oct 2027
- 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: Chronic Obstructive Pulmonary Disease (COPD) is a major disease that poses a serious threat to public health, with a prevalence rate of 13.7% in China for people aged 40 years and older, and a prevalence rate of 20.51% in high-risk groups, with a prevalence rate of COPD in high-risk groups of 33.39%, Early screening and identification are of great significance in delaying the progression of lung function and reducing the incidence of COPD. At the same time, patients with COPD are often comorbid with other diseases, and comorbidities have a significant impact on disease progression, consultation, hospitalization, morbidity and mortality, requiring more standardized and systematic recommendations to guide clinical practice.
Who may be able to join
- Meets diagnostic criteria for chronic obstructive pulmonary disease (COPD) or preserved ratio impaired spirometry (PRISm).
- Age ranges from 18 years to 80 years.
- The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.
Who cannot join
- Patients with delirium, dementia, various mental illnesses.
- Pregnant and planned pregnant or lactating women.
- Patients with other serious systemic diseases.
- Patients who, in the opinion of the investigator, are not suitable for participation in this study.
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 Chinese Medicine
Zhengzhou, Henan
Yang Xie, Ph.D, +8613526621325, xieyanghn@163.com
About this study
Official title: Respiratory Disease Cohort Studies of Chinese Medicine for Chronic Obstructive Pulmoriary Disease (RESEARCH-COPD)
This study will establish a registration research platform, a clinical research database and a biospecimen bank for the prevention and treatment of COPD with Chinese medicine. Based on the COPD registry database, a cohort of Chinese medicine for COPD prevention and treatment will be established.
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease with high prevalence, high mortality rate, high disability rate and heavy disease burden, seriously endangering people\'s health. The prevalence of COPD among people aged 40 and above in China is 13.7%, with nearly 100 million patients. The situation of high prevalence, high mortality, and high disability is not matched by the low awareness rate, low lung function test rate, and low treatment rate, which is a serious situation for prevention and control. 2021 edition of 'Global Initiative on Chronic Obstructive Lung Disease (GOLD)' puts forward the concept of pre-COPD, which indicates that the concept of prevention and treatment of COPD has begun to change to prevention and early intervention, and is also related to the concept of intermediate medicine. The concept of pre-COPD has been proposed in the 2021 edition of GOLD, indicating that the concept of prevention and treatment of COPD has begun to shift towards prevention and early intervention, which is also in line with the idea of 'treating the disease before it is diagnosed' in TCM. Chinese medicine has certain advantages in the prevention and treatment of COPD. Currently, there is a lack of TCM diagnostic and treatment protocols for the early stage of COPD, and TCM diagnostic and treatment protocols for the stable stage of COPD need to be optimised. Therefore, based on the Chinese COPD registry management system, this study took the pre-CPD population and stable stage patients as the research object, and used the standardised use of Chinese medicine diagnostic and treatment protocols as the exposure factor to carry out a multicentre prospective cohort study, with a follow-up of 2 years, using the morbidity rate, the rate of decline in lung function FEV1, etc., to evaluate the efficacy of Chinese medicine diagnostic and treatment protocols for pre-COPD, and using the rate of occurrence of acute exacerbation, The efficacy of TCM treatment protocols for patients with stable COPD was further evaluated using the incidence of acute exacerbation and quality of survival. This will provide high-quality evidence-based medical evidence for the prevention and treatment of COPD by TCM.
- Conditions
- Chronic Obstructive Pulmoriary Disease (COPD), Preserved Ratio Impaired Spirometry (PRISM)
- Being tested
- traditional Chinese medicine (TCM), non traditional Chinese medicine (non-TCM)
- Keywords
- Chronic Obstructive Pulmoriary Disease (COPD), Preserved Ratio Impaired Spirometry (PRISM), Complication (medicine), Traditional Chinese Medicine, Registration, Cohort study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional Chinese medicine (TCM)Drug
Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure was defined as taking the medication continuously for more than 3 months per year, or taking the medication intermittently for more than 6 months per year. According to the standardised use of TCM protocols, the group was divided into an exposed group (TCM protocols cohort) and a non-exposed group (non-TCM protocols cohort).
non traditional Chinese medicine (non-TCM)Drug
Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure was defined as taking the medication continuously for more than 3 months per year, or taking the medication intermittently for more than 6 months per year. According to the standardised use of TCM protocols, the group was divided into an exposed group (TCM protocols cohort) and a non-exposed group (non-TCM protocols cohort).
| Study group | Role | What they receive |
|---|---|---|
| Traditional Chinese Medicine cohort | Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Continuous medication for more than 3 months per year, or intermittent medication for more than 6 months per year was the exposure group (TCM diagnosis and treatment plan cohort). Receives: Drug: traditional Chinese medicine (TCM) | |
| Non Traditional Chinese Medicine cohort | Other patients who did not fit into the TCM group. Receives: Drug: non traditional Chinese medicine (non-TCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequencies of acute exacerbations (AEs)
The frequencies of acute exacerbations (AEs) will be recorded.
Measured: Frequency of acute exacerbations at months 3, 6, 9, 12, 15, 18, 21, and 24.
Incidence of COPD
The incidence of COPD will be recorded.
Measured: 24 months after enrollment.
Secondary outcomes (8)
6 Six Minute Walk Distance (6MWD)
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Measured: 6MWD at months 3, 6, 9, 12, 15, 18, 21, and 24.
Traditional Chinese medicine syndromes
The Traditional Chinese medicine syndromes will be recorded.
Measured: The Traditional Chinese medicine syndromes at months 3, 6, 9, 12, 15, 18, 21, and 24.
Forced expiratory volume in one second (FEV1)
FEV1 will be applied to assess pulmonary function.
Measured: Change from baseline FEV1 at months 6, 12, 18 and 24.
Forced vital capacity (FVC)
FVC will be applied to assess pulmonary function.
Measured: Change from baseline FVC at months 6, 12, 18 and 24.
FVC as the percentage of the predicted value (FVC%)
FVC% will be applied to assess pulmonary function.
Measured: Change from baseline FVC% at months 6, 12, 18 and 24.
Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)
FEV1/FVC will be applied to assess pulmonary function.
Measured: Change from baseline FEV1/FVC at months 6, 12, 18 and 24.
Diffusing capacity of the lungs for carbon monoxide (DLCO)
DLCO will be applied to assess pulmonary function.
Measured: Change from baseline DLCO at months 6, 12, 18 and 24.
COPD Assessment Test (CAT)
CAT will be applied to assess quality of life.
Measured: At months 6, 12, 18 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Oct 2024 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmoriary Disease (COPD)Studies 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
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiansheng Li, Professor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577701
- Sponsor's protocol ID
- RESEARCH-COPD
- Status last verified
- Nov 2023
- First submitted
- 27 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Disease Cohort Studies of Chinese Medicine for Chronic Obstructive Pulmoriary Disease (RESEARCH-COPD)
- ClinicalTrials.gov ID
- NCT06577701
- Acronym / sponsor ID
- RESEARCH-COPD
- Conditions
- Chronic Obstructive Pulmoriary Disease (COPD), Preserved Ratio Impaired Spirometry (PRISM)
- Keywords
- Chronic Obstructive Pulmoriary Disease (COPD), Preserved Ratio Impaired Spirometry (PRISM), Complication (medicine), Traditional Chinese Medicine, Registration, Cohort study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 29 Aug 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.
This study will establish a registration research platform, a clinical research database and a biospecimen bank for the prevention and treatment of COPD with Chinese medicine. Based on the COPD registry database, a cohort of Chinese medicine for COPD prevention and treatment will be established.
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease with high prevalence, high mortality rate, high disability rate and heavy disease burden, seriously endangering people\'s health. The prevalence of COPD among people aged 40 and above in China is 13.7%, with nearly 100 million patients. The situation of high prevalence, high mortality, and high disability is not matched by the low awareness rate, low lung function test rate, and low treatment rate, which is a serious situation for prevention and control. 2021 edition of 'Global Initiative on Chronic Obstructive Lung Disease (GOLD)' puts forward the concept of pre-COPD, which indicates that the concept of prevention and treatment of COPD has begun to change to prevention and early intervention, and is also related to the concept of intermediate medicine. The concept of pre-COPD has been proposed in the 2021 edition of GOLD, indicating that the concept of prevention and treatment of COPD has begun to shift towards prevention and early intervention, which is also in line with the idea of 'treating the disease before it is diagnosed' in TCM. Chinese medicine has certain advantages in the prevention and treatment of COPD. Currently, there is a lack of TCM diagnostic and treatment protocols for the early stage of COPD, and TCM diagnostic and treatment protocols for the stable stage of COPD need to be optimised. Therefore, based on the Chinese COPD registry management system, this study took the pre-CPD population and stable stage patients as the research object, and used the standardised use of Chinese medicine diagnostic and treatment protocols as the exposure factor to carry out a multicentre prospective cohort study, with a follow-up of 2 years, using the morbidity rate, the rate of decline in lung function FEV1, etc., to evaluate the efficacy of Chinese medicine diagnostic and treatment protocols for pre-COPD, and using the rate of occurrence of acute exacerbation, The efficacy of TCM treatment protocols for patients with stable COPD was further evaluated using the incidence of acute exacerbation and quality of survival. This will provide high-quality evidence-based medical evidence for the prevention and treatment of COPD by TCM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine cohort | – | Drug: traditional Chinese medicine (TCM)Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Continuous medication for more than 3 months per year, or intermittent medication for more than 6 months per year was the exposure group (TCM diagnosis and treatment plan cohort). |
| Non Traditional Chinese Medicine cohort | – | Drug: non traditional Chinese medicine (non-TCM)Other patients who did not fit into the TCM group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic Obstructive Pulmonary Disease (COPD) is a major disease that poses a serious threat to public health, with a prevalence rate of 13.7% in China for people aged 40 years and older, and a prevalence rate of 20.51% in high-risk groups, with a prevalence rate of COPD in high-risk groups of 33.39%, Early screening and identification are of great significance in delaying the progression of lung function and reducing the incidence of COPD. At the same time, patients with COPD are often comorbid with other diseases, and comorbidities have a significant impact on disease progression, consultation, hospitalization, morbidity and mortality, requiring more standardized and systematic recommendations to guide clinical practice.
Key inclusion criteria (3 listed)
- Meets diagnostic criteria for chronic obstructive pulmonary disease (COPD) or preserved ratio impaired spirometry (PRISm).
- Age ranges from 18 years to 80 years.
- The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.
Key exclusion criteria (4 listed)
- Patients with delirium, dementia, various mental illnesses.
- Pregnant and planned pregnant or lactating women.
- Patients with other serious systemic diseases.
- Patients who, in the opinion of the investigator, are not suitable for participation in this study.
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 |
|---|---|---|
| traditional Chinese medicine (TCM)Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure was defined as taking the medication continuously for more than 3 months per year, or taking the medication intermittently for more than 6 months per year. According to the standardised use of TCM protocols, the group was divided into an exposed group (TCM protocols cohort) and a non-exposed group (non-TCM protocols cohort). | Drug | Traditional Chinese Medicine cohort |
| non traditional Chinese medicine (non-TCM)Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure was defined as taking the medication continuously for more than 3 months per year, or taking the medication intermittently for more than 6 months per year. According to the standardised use of TCM protocols, the group was divided into an exposed group (TCM protocols cohort) and a non-exposed group (non-TCM protocols cohort). | Drug | Non Traditional Chinese Medicine cohort |
Primary outcome
Frequencies of acute exacerbations (AEs)
Time frame: Frequency of acute exacerbations at months 3, 6, 9, 12, 15, 18, 21, and 24.
The frequencies of acute exacerbations (AEs) will be recorded.
Incidence of COPD
Time frame: 24 months after enrollment.
The incidence of COPD will be recorded.
8 secondary outcomes
6 Six Minute Walk Distance (6MWD)
Time frame: 6MWD at months 3, 6, 9, 12, 15, 18, 21, and 24.
Traditional Chinese medicine syndromes
Time frame: The Traditional Chinese medicine syndromes at months 3, 6, 9, 12, 15, 18, 21, and 24.
Forced expiratory volume in one second (FEV1)
Time frame: Change from baseline FEV1 at months 6, 12, 18 and 24.
Forced vital capacity (FVC)
Time frame: Change from baseline FVC at months 6, 12, 18 and 24.
FVC as the percentage of the predicted value (FVC%)
Time frame: Change from baseline FVC% at months 6, 12, 18 and 24.
Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)
Time frame: Change from baseline FEV1/FVC at months 6, 12, 18 and 24.
Diffusing capacity of the lungs for carbon monoxide (DLCO)
Time frame: Change from baseline DLCO at months 6, 12, 18 and 24.
COPD Assessment Test (CAT)
Time frame: At months 6, 12, 18 and 24.
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 19 Sep 2024.
Related trials for Chronic Obstructive Pulmoriary Disease (COPD)
Not yet recruiting
Clinical Study on the Treatment of Chronic Airway Diseases (Asthma, Chronic Obstructive Pulmonary Disease) with Shu Fei Tie
Chronic Obstructive Pulmoriary Disease (COPD), Asthma
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.
Jiansheng 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 Chronic Obstructive Pulmoriary Disease (COPD) and Preserved Ratio Impaired Spirometry (PRISM), 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 3 inclusion and 4 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 19 Sep 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 Yang Xie, Ph.D (13526621325, xieyanghn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequencies of acute exacerbations (AEs) (time frame: Frequency of acute exacerbations at months 3, 6, 9, 12, 15, 18, 21, and 24.). The study lists 2 primary outcomes in all. 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 19 Sep 2024.