Clinical trial NCT06326658: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Bufei Yishen Prescription
AECOPD
remission period
frequent
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
First posted: 2024-03-22
Enrollment: 848
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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.

Primary outcomes:
measure: The number of acute exacerbations
timeFrame: Change from baseline the number of acute exacerbations at month 3, 6, 9and 12.
Secondary outcomes:
measure: The number of AECOPD leading to hospitalization and death
timeFrame: Change from baseline the number of AECOPD leading to hospitalization and death at month 3, 6, 9 and 12.
measure: Time of onset of the first AECOPD
timeFrame: Immediately after the intervention
measure: Severity of AECOPD
timeFrame: Change from baseline severity of AECOPD at month 3, 6, 9and 12.
measure: Duration of AECOPD
timeFrame: Change from baseline duration of AECOPD at month 3, 6, 9and 12.
measure: Case fatality rate
timeFrame: Up to month 12
measure: Lung function
timeFrame: Change from baseline lung function at month 3, 6, 9and 12.
measure: Score for clinical signs and symptoms
timeFrame: Change from baseline clinical symptoms and signs at month 3, 6, 9and 12.
measure: 6-minute walking distance (6MWD)
timeFrame: Change from baseline 6-minute walking distance (6MWD) at month 3, 6, 9and 12.
measure: The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT)
timeFrame: Change from baseline the chronic obstructive pulmonary patient self-assessment test (CAT) at month 3, 6, 9and 12.
measure: The MOS item short fromhealth survey（SF-36）
timeFrame: Change from baseline SF-36 scale at month 3, 6, 9and 12.
Other outcomes:
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