Bufei Jianpi Granule for Delaying Pulmonary Function Decline in Early-Stage COPD

Henan University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Placebo Bufei Jianpi granule; Drug: Bufei Jianpi granule

Study type: Interventional

Funder types: Other

Identifiers

NCT03976700

TCM for Early-Stage COPD

Details and patient eligibility

About

This study aims to establish the treatment scheme of Bufei Jianpi granule for early-stage (GOLD stage 1 or 2) chronic obstructive pulmonary disease (COPD), delaying pulmonary function decline and forming high quality evidence.

Full description

COPD is a highly prevalent disease, with a prevalence among people 40 years of age or older of 10.1% worldwide and 13.7% in China. COPD has become the third leading cause of death worldwide. More than 70% of patients with COPD are in GOLD stage 1 (mild) or 2 (moderate), with very mild or no apparent respiratory symptoms such as dyspnea. The Tiotropium in Early Chronic Obstructive Pulmonary Disease Patients in China (Tie-COPD) trial was designed to investigate the effect of tiotropium on the FEV1 in COPD patients with GOLD stage 1 or 2. The investigator's previous studies also suggested that traditional Chinese medicine (TCM) has effect on GOLD stage 1 or 2 COPD.

This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of Bufei Jianpi granule for delaying pulmonary function decline in early-stage (GOLD stage 1 or 2) COPD subjects. After a 14-day run-in period, 612 subjects will be randomly assigned to treatment group or control group for 104-week treatment. The primary outcomes include pulmonary function and frequency of acute exacerbation. The secondary outcomes include clinical symptoms, dyspnea, exercise capacity, quality of life and treatment satisfaction. Safety will also be assessed.

Enrollment: 612 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A confirmed diagnosis of early-stage (GOLD stage 1 or 2) COPD.
• Syndrome differentiation meets criteria of Qi deficiency of the lung syndrome, Qi deficiency of the lung and spleen syndrome or Qi deficiency of the lung and kidney syndrome.
• Age ranges from 40 years to 80 years.
• With informed consent signed.

Exclusion criteria

• Pregnant and lactating women.
• Patients with severe cardiovascular and cerebrovascular diseases.
• Patients with severe liver and kidney diseases.
• Patients with asthma, bronchiectasis, active pulmonary tuberculosis, pulmonary embolism or other severe respiratory diseases.
• Patients with tumor after resection, radiotherapy or chemotherapy in the past 5 years.
• Patients with severe neuromuscular disorders, severe arthritis or severe peripheral vascular diseases.
• Patients with severe cognitive and psychiatric disorders.
• Patients with diabetes.
• People who are allergic to the treatment drugs.
• Patients who have participated in other clinical studies in the past 4 weeks.
• Patients who have experienced one or more acute exacerbation in the past 4 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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612 participants in 2 patient groups, including a placebo group

Bufei Jianpi granule

Experimental group

Description:

Patients in this arm will receive Bufei Jianpi granule.

Treatment:

Drug: Bufei Jianpi granule

Placebo Bufei Jianpi granule

Placebo Comparator group

Description:

Patients in this arm will receive placebo Bufei Jianpi granule.

Treatment:

Drug: Placebo Bufei Jianpi granule