Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06326658
• Other study ID #: TCM for Frequent AECOPD
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: October 31, 2026

Study information

• Verified date: March 2024
• Source: Henan University of Traditional Chinese Medicine
• Contact: Minghang Wang, MD
• Phone: 0371-66248624
• Email: wmh107hn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 848
• Est. completion date: October 31, 2026
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine	The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	Time of onset of the first AECOPD	the interval between the first medication and the first AECOPD (days).	Immediately after the intervention
Secondary	Severity of AECOPD	mild, moderate and severe	Change from baseline severity of AECOPD at month 3, 6, 9and 12.
Secondary	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.
Secondary	Case fatality rate	including the case fatality rate of AECOPD and the all-cause case fatality rate	Up to month 12
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.