Clinical trial NCT06375824: Bufei Recipe Reduces the Incidence Rate of COPD
Official title: Bufei Recipe Reduces the Incidence Rate of COPD: A Multicenter, Randomized, Double Blind, Placebo Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Preserved Ratio Impaired Spirometry
Keywords: Bufei Recipe
PRISm
incidence rate
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: The First Affiliated Hospital of Zhejiang Chinese Medical University
First posted: 2024-04-19
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Establish early TCM prevention and treatment program to reduce the incidence rate of COPD.

Detailed description: Taking PRISM patients with impaired lung function at the early stage of COPD retention ratio as the research object, and aiming at the key problems such as the lack of prevention and treatment plan, a two-year randomized double-blind placebo controlled clinical study of Bufei Fang was carried out to establish the early stage TCM prevention and treatment plan to reduce the incidence rate of COPD.

Eligibility criteria: Inclusion Criteria:

1. Risk factors for chronic obstructive pulmonary disease. Having one item from a, b, and c (risk factors will be further optimized based on the screening results of high-risk populations):

   1. smoking history (including previous and current smokers);
   2. 1 year or more of exposure to dust or chemical toxins;
   3. Indoor air pollution for 1 year or more (use of contaminated fuels, passive smoking, exposure) Oil fumes, etc.
2. Have a history of chronic bronchitis and/or emphysema, and have one of the following chronic respiratory symptoms:

   1. Cough (more than 3 months per year, continuous for 2 years or more);
   2. Coughing phlegm (more than 3 months per year, continuous for 2 years or more);
   3. Difficulty breathing (more than 3 months per year, continuous for 2 years or more).
3. The lung function test meets the following criteria: forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ≥ 70% and FEV1 accounting for%\<80% of the expected value.
4. Meets the diagnostic criteria for lung qi deficiency syndrome.
5. Age range from 18 to 80 years old.
6. Voluntarily participate in the study and sign an informed consent form.

Exclusion Criteria:

* Pregnant and planned pregnancy, lactating women.
* Dementia and various mental illness patients.
* Other diseases with chronic cough, sputum production, or difficulty breathing.
* Merge tumors.
* Merge severe cardiovascular and cerebrovascular diseases.
* Concomitant severe liver and kidney diseases.
* Participants in clinical trials of other drugs.
* Allergies to intervention drugs.

Primary outcomes:
measure: Incidence rate of COPD
timeFrame: Change from baseline in the number of people with COPD at month 24.
Secondary outcomes:
measure: FVC
timeFrame: Change from baseline in FVC at months 12 and 24.
measure: FEV1
timeFrame: Change from baseline in FEV1 at months 12 and 24.
measure: FEV1% pred
timeFrame: Change from baseline in FEV1% pred at months 12 and 24.
measure: FEV1/FVC
timeFrame: Change from baseline in FEV1/FVC at months 12 and 24.
measure: IPAG-Q
timeFrame: Change from baseline in IPAG-Q score at months 6, 12, 18, and 24.
measure: LFQ
timeFrame: Change from baseline in LFQ score at months 6, 12, 18, and 24.
measure: COPD-PS
timeFrame: Change from baseline in COPD-PS score at months 6, 12, 18, and 24.
measure: CAT
timeFrame: Change from baseline in CAT score at months 6, 12, 18, and 24.
measure: SF-36
timeFrame: Change from baseline in SF-36 score at months 6, 12, 18, and 24.
measure: Clinical symptoms
timeFrame: Change from baseline in clinical symptom assessment questionnaire score at months 6, 12, 18, and 24.
measure: Biochemical indicators
timeFrame: Change from baseline in biochemical indicators at month 12 and 24.
Other outcomes:
Locations:
Study officials:
References: