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NCT Number: NCT06577701

Respiratory Disease Cohort Studies of Chinese Medicine for COPD(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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

Location contact

Yang Xie, Ph.D

CONTACT

[email protected]

+8613526621325

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. 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.

  2. Incidence of COPD

    Time frame: 24 months after enrollment.

    The incidence of COPD will be recorded.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. COPD Assessment Test (CAT)

    Time frame: At months 6, 12, 18 and 24.

    CAT will be applied to assess quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Yang Xie, Ph.D

CONTACT

[email protected]

13526621325

Sponsors and collaborators

Lead sponsor

Henan University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 29, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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