Respiratory Disease Cohort Studies of Chinese Medicine for COPD(RESEARCH-COPD)

August 27, 2024 updated by: Henan University of Traditional Chinese Medicine

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 against COPD will be established.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

10000

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

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Henan University of Chinese Medicine
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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).
Drug: 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).
Non Traditional Chinese Medicine cohort
Other patients who did not fit into the TCM group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Frequency of acute exacerbations at months 3, 6, 9, 12, 15, 18, 21, and 24.
Incidence of COPD
Time Frame: 24 months after enrollment.
The incidence of COPD will be recorded.
24 months after enrollment.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
6 Six Minute Walk Distance (6MWD)
Time Frame: 6MWD at months 3, 6, 9, 12, 15, 18, 21, and 24.
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
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.
The Traditional Chinese medicine syndromes will be recorded.
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.
FEV1 will be applied to assess pulmonary function.
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 will be applied to assess pulmonary function.
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.
FVC% will be applied to assess pulmonary function.
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.
FEV1/FVC will be applied to assess pulmonary function.
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.
DLCO will be applied to assess pulmonary function.
Change from baseline DLCO at months 6, 12, 18 and 24.
COPD Assessment Test (CAT)
Time Frame: At months 6, 12, 18 and 24.
CAT will be applied to assess quality of life.
At months 6, 12, 18 and 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan University of Traditional Chinese Medicine

Investigators

  • Study Chair: Jiansheng LI, Professor, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

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 (Estimated)

September 1, 2024

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

October 30, 2027

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RESEARCH-COPD

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.

Subscribe