Bufei Recipe Reduces the Incidence Rate of COPD

Bufei Recipe Reduces the Incidence Rate of COPD: A Multicenter, Randomized, Double Blind, Placebo Controlled Study

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

Study Overview

• Status: Not yet recruiting
• Conditions: Preserved Ratio Impaired Spirometry
• Intervention / Treatment: Drug: Bufei Recipe; Drug: Bufei Recipe placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 1100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: yang xie; Phone Number: 0371-66248624; Email: xieyanhn@163.com
• Study Contact Backup: Name: yang xie; Phone Number: 13526621325; Email: xieyanhn@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bufei Recipe; Bu Fei Fang: Roasted Astragalus, Codonopsis pilosula, Walnut kernels, Sichuan Fritillaria, Angelica sinensis, Stir fried Purple Su Zi, Honey Baibu, Roasted Purple Aster, etc. Take 1 dose daily, 5 days a week.	Drug: Bufei Recipe; Bufei Recipe: Roasted Astragalus, Codonopsis pilosula, Walnut kernels, Sichuan Fritillaria, Angelica sinensis, Stir fried Purple Su Zi, Honey Baibu, Roasted Purple Aster, etc. Take 1 dose daily, 5 days a week.
Placebo Comparator: Bufei Recipe placebo; The placebo was prepared using 5% of the drug, with color, odor, taste, appearance, and weight similar to the experimental group drug, and packaging consistent with the experimental group drug.	Drug: Bufei Recipe placebo; The placebo was prepared using 5% of the drug, with color, odor, taste, appearance, and weight similar to the experimental group drug, and packaging consistent with the experimental group drug.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of COPD	Incidence rate of COPD	Change from baseline in the number of people with COPD at month 24.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FVC	Forced Vital Capacity (FVC) was mainly used for lung function evaluation	Change from baseline in FVC at months 12 and 24.
FEV1	Forced Expiratory Volume in One Second (FEV1) was mainly used for lung function evaluation	Change from baseline in FEV1 at months 12 and 24.
FEV1% pred	Percentage of Forced Expiratory Volume in One Second to Predicted Value (FEV1% pred) was mainly used for lung function evaluation	Change from baseline in FEV1% pred at months 12 and 24.
FEV1/FVC	Forced Expiratory Volume in One Second / Forced Vital Capacity (FEV1/FVC) was mainly used for lung function evaluation	Change from baseline in FEV1/FVC at months 12 and 24.
IPAG-Q	International Primary Airway Health Organization Questionnaire (IPAG-Q) was mainly used for chronic obstructive pulmonary screening score evaluation.	Change from baseline in IPAG-Q score at months 6, 12, 18, and 24.
LFQ	Lung Function Questionnaire (LFQ) was mainly used for chronic obstructive pulmonary screening score evaluation.	Change from baseline in LFQ score at months 6, 12, 18, and 24.
COPD-PS	Chronic Obstructive Pulmonary Disease Population Screening Questionnaire (COPD-PS) was mainly used for chronic obstructive pulmonary screening score evaluation.	Change from baseline in COPD-PS score at months 6, 12, 18, and 24.
CAT	Chronic Obstructive Pulmonary Disease Assessment (CAT) was mainly used for quality of life evaluation.	Change from baseline in CAT score at months 6, 12, 18, and 24.
SF-36	Health Survey Brief (SF-36) was mainly used for quality of life evaluation.	Change from baseline in SF-36 score at months 6, 12, 18, and 24.
Clinical symptoms	The assessment will be done through a clinical symptom assessment questionnaire. Clinical symptoms assessed in this study include cough, sputum, wheezing, chest tightness, shortness of breath, malaise and cyanosis. Each symptom or sign will receive a score of 0-3, with higher scores indicating greater severity of the condition.	Change from baseline in clinical symptom assessment questionnaire score at months 6, 12, 18, and 24.
Biochemical indicators	Serum levels of TNF- α, IL-1, IL-6, immunoglobulin and renal connexin, prolyl peptidase, heme oxygenase-1, superoxide dismutase, glutathione peroxidase and angiotensin-converting enzyme were measured. All indicators were measured in ng/ml.	Change from baseline in biochemical indicators at month 12 and 24.

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine
• Collaborators: West China Hospital; The First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: April 2, 2024
• First Submitted That Met QC Criteria: April 16, 2024
• First Posted (Actual): April 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: incidence rate; PRISm; Bufei Recipe
• Other Study ID Numbers: TCM for Pre-COPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No