NCT03976713

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

Bufei Yishen Granule for Reducing Acute Exacerbation in GOLD Stage 3 or 4 COPD: A Randomized, Double-blind, Placebo Controlled Trial

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 348 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Bufei Yishen granule	Bufei Yishen granule will be administered twice daily for five days a week for 52 weeks.
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.
DRUG	Tiotropium Bromide Powder for Inhalation	Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks.

Timeline

• Start date: 2019-06-01
• Primary completion: 2020-06-01
• Completion: 2020-12-01
• First posted: 2019-06-06
• Last updated: 2019-06-06

Locations

1 site across 1 country: China