Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage

Evaluation of the Curative Effect and Health Economics of Bufei Yishen Prescription on Patients With Frequent Acute Exacerbation of COPD in Stable Stage

To evaluate the clinical efficacy and health economic advantages of Lung Replenishing and Kidney Enhancing Formula for the treatment of patients with frequent acute exacerbations in the stabilized phase.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Bufei Yishen Prescription Granule

Detailed Description

This study is based on a real world using a multicenter, randomized, double-blind, placebo-controlled trial.Based on a real-world multi-center, randomized, double-blind, placebo-controlled trial, this study will clinically observe patients with frequent acute exacerbations of chronic obstructive pulmonary disease in the stable phase.The study will evaluate the clinical efficacy and safety of Chinese medicine treatment programs in patients with frequent acute exacerbations of stable chronic obstructive pulmonary disease, and provide high-quality evidence for the popularization and application of Chinese medicine therapy in chronic obstructive pulmonary disease.This study will scientifically evaluate the clinical efficacy and safety of TCM treatment programs in patients with frequent acute exacerbations of stable chronic obstructive pulmonary disease, and provide high-quality evidence for the popularization of TCM evidence-based treatment in chronic obstructive pulmonary disease.

• Study Type: Interventional
• Enrollment (Estimated): 848
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Minghang Wang, MD; Phone Number: 0371-66248624; Email: wmh107hn@163.com
• Study Contact Backup: Name: Minghang Wang, MD; Phone Number: 18638392188; Email: wmh107hn@163.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients diagnosed with COPD at a stable stage.
• Stable COPD patients with frequent acute exacerbation.
• Age 40-80 years old.
• The condition was stable 4 weeks before enrollment.
• 5 did not participate in other drug clinical studies within 1 month before enrollment.
• At least 3 months of maintenance therapy with triple inhalation preparation was used before enrollment.
• Washout period was 2 weeks before enrollment.
• Voluntarily receive treatment and sign informed consent.

Exclusion Criteria:

• complicity with other diagnosed and clinically significant respiratory diseases, including but not limited to: asthma, active pulmonary tuberculosis, bronchiectasis, pulmonary hypertension, pulmonary embolism, pneumothorax, pleural effusion, interstitial lung disease, or other active pulmonary diseases requiring intervention.
• Patients with severe or acute cardiovascular and cerebrovascular diseases (acute cardiovascular and cerebrovascular events, malignant arrhythmias, unstable angina pectoris, cardiac function grade 3 or above, uncontrolled hypertension, etc.).
• Complicated with severe liver and kidney disease (severe liver disease refers to cirrhosis, portal hypertension and varicose vein bleeding, serious kidney disease including dialysis, kidney transplantation).
• Any item of liver function index (ALT, AST) exceeds the upper limit of normal reference value by 1.5 times, and renal function index Scr exceeds the upper limit of normal reference value.
• Tumor patients who have undergone surgical resection, radiotherapy and chemotherapy in the past five years.
• Patients with mobility difficulties caused by severe osteoarthropathy, neuromuscular disease, and peripheral vascular disease.
• Combined with absolute or relative prohibition of 6-minute walking test: such as resting heart rate > 120 beats/min, systolic blood pressure > 180mmHg or diastolic blood pressure > 100mmHg; Or have limited activity to complete the 6-minute walking test.
• Combined with cognitive or mental disorders.
• Glucocorticoids were taken orally within 2 weeks before enrollment.
• Had taken any Chinese medicine preparations (decoction, formula granule, proprietary Chinese medicine, etc.) prohibited during the study period according to the protocol within 2 weeks before enrollment.
• People who are known to be allergic to therapeutic drugs.
• Pregnant and lactating women, people who plan to become pregnant or cannot use effective contraceptive measures.

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 Yishen Prescription; Bufei Yishen formula consists of Radix Panax Ginseng 6g, Radix Astragali 15g, Cornu Cervi Pantotrichum 12g, Fructus Lycii 12g, Fructus Schisandrae Chinensis 9g, Fructus Epimedium Brevicornum 9g, Fructus Pelargonium Chinense 9g, Radix Paeoniae Lactiflorae 9g, Rhizoma Dillonis 9g, Fructus Ziziphiroxylon 9g, Fructus Schisandrae Chinense 15g, Pericarpium Citriodora 9g	Other: Bufei Yishen Prescription Granule; The comparison group was given Bufei Yishen Prescription Granule.The course of treatment was the same as that of the experimental group.
Placebo Comparator: Bufei Yishen Prescription placebo; Bufei Yishen Prescription placebo is prepared by adding 5% of the drug on the basis of dextrin and bitter agent, and its appearance, weight, color and smell are consistent with Chinese medicine granules.	Other: Bufei Yishen Prescription Granule; The comparison group was given Bufei Yishen Prescription Granule.The course of treatment was the same as that of the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of acute exacerbations	The number of acute exacerbations	Change from baseline the number of acute exacerbations at month 3, 6, 9and 12.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of AECOPD leading to hospitalization and death	Deaths due to AECOPD should be recorded in the study diary.	Change from baseline the number of AECOPD leading to hospitalization and death at month 3, 6, 9 and 12.
Time of onset of the first AECOPD	the interval between the first medication and the first AECOPD (days).	Immediately after the intervention
Severity of AECOPD	mild, moderate and severe	Change from baseline severity of AECOPD at month 3, 6, 9and 12.
Duration of AECOPD	The duration of acute exacerbation is from the beginning of an acute exacerbation to the stabilization of the disease	Change from baseline duration of AECOPD at month 3, 6, 9and 12.
Case fatality rate	including the case fatality rate of AECOPD and the all-cause case fatality rate	Up to month 12
Lung function	FVC, FEV1, FEV1 % of the estimated value, FEV1/FVC were mainly used for evaluation	Change from baseline lung function at month 3, 6, 9and 12.
Score for clinical signs and symptoms	Formulate with reference to the "Guidelines for Clinical Research of New Chinese Medicines"Clinical scoring is weighted or assigned according to some of the main symptoms, signs, physiological parameters of patients, etc., so as to quantitatively evaluate the severity of the disease.The higher the score, the worse the state.	Change from baseline clinical symptoms and signs at month 3, 6, 9and 12.
6-minute walking distance (6MWD)	The 6-minute walking test standard published by ERS and ATS was adopted	Change from baseline 6-minute walking distance (6MWD) at month 3, 6, 9and 12.
The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT)	The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT), with a score range of 0 to 40.The higher the score, the worse the state.	Change from baseline the chronic obstructive pulmonary patient self-assessment test (CAT) at month 3, 6, 9and 12.
The MOS item short fromhealth survey（SF-36）	SF-36 Includes 8 dimensions: physical functioning, physical functioning, somatic pain, general health status, social functioning, emotional functioning, and mental health.The higher the score, the worse the state.	Change from baseline SF-36 scale at month 3, 6, 9and 12.

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine
• Collaborators: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine; The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 17, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 17, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: AECOPD; frequent; Bufei Yishen Prescription; remission period
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Chronic Disease; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: TCM for Frequent AECOPD

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