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

NCT ID: NCT03976700

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 612 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2021-12-31

Brief Summary

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.

Detailed 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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Bufei Jianpi granule

Patients in this arm will receive Bufei Jianpi granule.

Group Type: EXPERIMENTAL

Bufei Jianpi granule

Intervention Type: DRUG

Bufei Jianpi granule is composed of many kinds of traditional Chinese medicine. The granule will be administered twice daily for five days a week for 104 weeks.

Placebo Bufei Jianpi granule

Patients in this arm will receive placebo Bufei Jianpi granule.

Group Type: PLACEBO_COMPARATOR

Placebo Bufei Jianpi granule

Intervention Type: DRUG

Placebo Bufei Jianpi granule consists of dextrin, bitter and 5% of the Bufei Jianpi granule. The appearance, weight, color and odor of the preparation are the same as those of treatment group. The placebo granule will be administered twice daily for five days a week for 104 weeks.

Interventions

Bufei Jianpi granule

Bufei Jianpi granule is composed of many kinds of traditional Chinese medicine. The granule will be administered twice daily for five days a week for 104 weeks.

Intervention Type: DRUG

Placebo Bufei Jianpi granule

Placebo Bufei Jianpi granule consists of dextrin, bitter and 5% of the Bufei Jianpi granule. The appearance, weight, color and odor of the preparation are the same as those of treatment group. The placebo granule will be administered twice daily for five days a week for 104 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu Province Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiansheng Li, Professor

Role: STUDY_CHAIR

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Locations

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, China

Countries

China

Central Contacts

Suyun Li, Professor

Role: CONTACT

lisuyun2000@126.com

86-371-66248624

Facility Contacts

Suyun Li, Professor

Role: primary

lisuyun2000@126.com

86-371-66248624

Other Identifiers

TCM for Early-Stage COPD

Identifier Type: -

Identifier Source: org_study_id