Bufei Yishen Granule for Reducing Acute Exacerbation in GOLD Stage 3 or 4 COPD

NCT ID: NCT03976713

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 348 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2020-12-31

Brief Summary

This study aims to establish the treatment scheme of Bufei Yishen granule for GOLD stage 3 or 4 chronic obstructive pulmonary disease (COPD), reducing acute exacerbation, improving exercise capacity 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. Frequent acute exacerbation and exercise limitation broadly exist in COPD patients, especially those in GOLD stage 3 or 4. Although appropriate pharmacological therapies have been proven to be effective in COPD management, however, many gaps are still to be filled. For example, the adverse effects of pharmacologic therapies can never be ignored. The investigator's previous studies suggested that traditional Chinese medicine (TCM) has effect on GOLD stage 3 or 4 COPD.

This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of Bufei Yishen granule on reducing acute exacerbation in GOLD stage 3 or 4 COPD subjects. After a 14-day run-in period, 348 subjects will be randomly assigned to treatment group or control group for 52-week treatment. The primary outcomes are frequency and duration of acute exacerbation. The secondary outcomes include mortality, pulmonary function, clinical symptoms, 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 Yishen granule plus Western medicine

Patients in this arm will receive Bufei Yishen granule in addition to Western medicine.

Group Type: EXPERIMENTAL

Bufei Yishen granule

Intervention Type: DRUG

Bufei Yishen granule will be administered twice daily for five days a week for 52 weeks.

Tiotropium Bromide Powder for Inhalation

Intervention Type: DRUG

Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks.

Placebo Bufei Yishen granule plus Western medicine

Patients in this arm will receive placebo Bufei Yishen granule in addition to Western medicine.

Group Type: PLACEBO_COMPARATOR

Placebo Bufei Yishen granule

Intervention Type: DRUG

Placebo Bufei Yishen granule will be administered twice daily for five days a week for 52 weeks. The placebo granule consists of dextrin, bitter and 5% of the Bufei Yishen granule. The appearance, weight, color and odor of the preparation are the same as those of treatment group.

Tiotropium Bromide Powder for Inhalation

Intervention Type: DRUG

Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks.

Interventions

Bufei Yishen granule

Bufei Yishen granule will be administered twice daily for five days a week for 52 weeks.

Intervention Type: DRUG

Placebo Bufei Yishen granule

Placebo Bufei Yishen granule will be administered twice daily for five days a week for 52 weeks. The placebo granule consists of dextrin, bitter and 5% of the Bufei Yishen granule. The appearance, weight, color and odor of the preparation are the same as those of treatment group.

Intervention Type: DRUG

Tiotropium Bromide Powder for Inhalation

Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• A confirmed diagnosis of GOLD stage 3 or 4 COPD.
• Syndrome differentiation meets criteria of Qi deficiency of the lung and spleen syndrome, Qi deficiency of the lung and kidney syndrome or Qi and Yin 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, chronic respiratory failure 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.
• Patients who were administered oral glucocorticoids in the past 4 weeks.
• Patients who have participated in other clinical studies in the past 4 weeks.
• People who are allergic to the treatment drugs.
• 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

ShuGuang Hospital

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

Xueqing Yu, Doctor

Role: CONTACT

yxqshi@163.com

86-371-66248624

Facility Contacts

Xueqing Yu, Doctor

Role: primary

yxqshi@163.com

86-371-66248624

Other Identifiers

TCM for GOLD stage 3 or 4 COPD

Identifier Type: -

Identifier Source: org_study_id