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

NCT03976713 | Unknown Phase 3 DMC

• 1 other identifier: TCM for GOLD stage 3 or 4 COPD
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Bufei Yishen Granule; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (2)

• Frequency of acute exacerbation

  Frequency of acute exacerbation will be recorded.

  Up to week 52.

• Duration of acute exacerbation

  Duration of acute exacerbation will be recorded.

  Up to week 52.

Secondary Outcomes (8)

• Mortality

  Up to week 52.

• FEV1

  Change from baseline FEV1 at week 26 and 52.

• Clinical symptom assessment questionnaire

  Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39 and 52.

• 6MWD

  Change from baseline 6MWD at week 13, 26, 39 and 52.

• CAT

  Change from baseline CAT scores at week 13, 26, 39 and 52.

Study Arms (2)

Bufei Yishen granule plus Western medicine

EXPERIMENTAL

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

Drug: Bufei Yishen granule; Drug: Tiotropium Bromide Powder for Inhalation

Placebo Bufei Yishen granule plus Western medicine

PLACEBO COMPARATOR

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

Drug: Placebo Bufei Yishen granule; Drug: Tiotropium Bromide Powder for Inhalation

Interventions

Bufei Yishen granule DRUG

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

Bufei Yishen granule plus Western medicine

Placebo Bufei Yishen granule 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.

Placebo Bufei Yishen granule plus Western medicine

Tiotropium Bromide Powder for Inhalation DRUG

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

Bufei Yishen granule plus Western medicine; Placebo Bufei Yishen granule plus Western medicine

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• ShuGuang Hospital: collaborator

Study Sites (1)

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

Location

Related Publications (1)

• Yu XQ, Di JQ, Zhang W, Wei GS, Ma ZP, Wu L, Yu XF, Zhu HZ, Zhou M, Feng CL, Feng JH, Fan P, Li JS, Yang JY. Bu-Fei Yi-Shen Granules Reduce Acute Exacerbations in Patients with GOLD 3-4 COPD: A Randomized Controlled Trial. Int J Chron Obstruct Pulmon Dis. 2023 Nov 6;18:2439-2456. doi: 10.2147/COPD.S413754. eCollection 2023.

  PMID: 37955027 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Inhalation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiratory Mechanics; Respiration; Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Jiansheng Li, Professor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Xueqing Yu, Doctor

CONTACT

86-371-66248624; yxqshi@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 6, 2019
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: June 6, 2019

Record last verified: 2019-05

Locations

CN (1)