Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage

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

Overview

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.

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.

Interventions

• 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.

Primary outcome measures

• The number of acute exacerbations [Time frame: Change from baseline the number of acute exacerbations at month 3, 6, 9and 12.]

Secondary outcome measures (10)

• The number of AECOPD leading to hospitalization and death [Time frame: 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 [Time frame: Immediately after the intervention]
• Severity of AECOPD [Time frame: Change from baseline severity of AECOPD at month 3, 6, 9and 12.]
• Duration of AECOPD [Time frame: Change from baseline duration of AECOPD at month 3, 6, 9and 12.]
• Case fatality rate [Time frame: Up to month 12]
• Lung function [Time frame: Change from baseline lung function at month 3, 6, 9and 12.]
• Score for clinical signs and symptoms [Time frame: Change from baseline clinical symptoms and signs at month 3, 6, 9and 12.]
• 6-minute walking distance (6MWD) [Time frame: Change from baseline 6-minute walking distance (6MWD) at month 3, 6, 9and 12.]
• The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT) [Time frame: 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） [Time frame: Change from baseline SF-36 scale at month 3, 6, 9and 12.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Xiao Q, Wang M, Li Z, Chen T, Li J. Efficacy and health economics of Bufei Yishen granules in patients with frequent exacerbator phenotype in the stable phase of chronic obstructive pulmonary disease: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial. Front Med (Lausanne). 2025 Sep 3;12:1662655. doi: 10.3389/fmed.2025.1662655. eCollection 2025. PMID 40969810

Identifiers

NCT: NCT06326658 · TCM for Frequent AECOPD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗