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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Bufei Yishen granule

Placebo Bufei Yishen granule

Tiotropium Bromide Powder for Inhalation

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Bufei Yishen Granule, Randomized Controlled Trial

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bufei Yishen granule plus Western medicine

Placebo Bufei Yishen granule plus Western medicine

Arm Description

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

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

Outcomes

Primary Outcome Measures

Frequency of acute exacerbation

Frequency of acute exacerbation will be recorded.

Duration of acute exacerbation

Duration of acute exacerbation will be recorded.

Secondary Outcome Measures

Mortality

The mortality will be calculated.

FEV1

Forced expiratory volume in one second ( FEV1) will be used to assess pulmonary function.

Clinical symptom assessment questionnaire

Clinical symptom assessment questionnaire of COPD will be used to assess symptom.

6MWD

Six-minute walk distance (6MWD) will be conducted to assess exercise capacity

CAT

COPD assessment test (CAT) will be used to assess quality of life.

SF-36

The MOS 36-Item Short-Form Health Survey (SF-36) will be used to assess quality of life.

mCOPD-PRO

The modified COPD patient-reported outcome scale (mCOPD-PRO) will be used to assess quality of life. The mCOPD-PRO contains 27 items in three domains. mCOPD-PRO scores range from 0 to 4 with a decrease in score showing higher health status.

mESQ-COPD

The modified effectiveness satisfaction questionnaire for COPD (mESQ-COPD) will be used to assess treatment satisfaction. The mESQ-COPD contains 19 items in four domains. mESQ-COPD scores range from 0 to 4 with a decrease in score showing higher treatment satisfaction.

Full Information

NCT ID

NCT03976713

First Posted

May 29, 2019

Last Updated

June 5, 2019

Sponsor

Henan University of Traditional Chinese Medicine

Collaborators

ShuGuang Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03976713

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Unknown status

Study Start Date

June 2019 (Anticipated)

Primary Completion Date

June 2020 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Henan University of Traditional Chinese Medicine

Collaborators

ShuGuang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

348 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bufei Yishen granule plus Western medicine

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo Bufei Yishen granule plus Western medicine

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Bufei Yishen granule

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo Bufei Yishen granule

Intervention Description

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

Intervention Name(s)

Tiotropium Bromide Powder for Inhalation

Intervention Description

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

Primary Outcome Measure Information:

Title

Frequency of acute exacerbation

Description

Frequency of acute exacerbation will be recorded.

Time Frame

Up to week 52.

Title

Duration of acute exacerbation

Description

Duration of acute exacerbation will be recorded.

Time Frame

Up to week 52.

Secondary Outcome Measure Information:

Title

Mortality

Description

The mortality will be calculated.

Time Frame

Up to week 52.

Title

FEV1

Description

Forced expiratory volume in one second ( FEV1) will be used to assess pulmonary function.

Time Frame

Change from baseline FEV1 at week 26 and 52.

Title

Clinical symptom assessment questionnaire

Description

Clinical symptom assessment questionnaire of COPD will be used to assess symptom.

Time Frame

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

Title

6MWD

Description

Six-minute walk distance (6MWD) will be conducted to assess exercise capacity

Time Frame

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

Title

CAT

Description

COPD assessment test (CAT) will be used to assess quality of life.

Time Frame

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

Title

SF-36

Description

The MOS 36-Item Short-Form Health Survey (SF-36) will be used to assess quality of life.

Time Frame

Change from baseline SF-36 scores at week 13, 26, 39 and 52.

Title

mCOPD-PRO

Description

Time Frame

Change from baseline mCOPD-PRO scores at week 13, 26, 39 and 52.

Title

mESQ-COPD

Description

Time Frame

Change from baseline mESQ-COPD scores at week 13, 26, 39 and 52.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xueqing Yu, Doctor

Phone

86-371-66248624

yxqshi@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jiansheng Li, Professor

Organizational Affiliation

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Official's Role

Study Chair

Facility Information:

Facility Name

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450000

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xueqing Yu, Doctor

Phone

86-371-66248624

yxqshi@163.com

12. IPD Sharing Statement

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

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