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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Bufei Jianpi granule

Placebo Bufei Jianpi granule

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Bufei Jianpi 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 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.

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 Jianpi granule

Placebo Bufei Jianpi granule

Arm Description

Patients in this arm will receive Bufei Jianpi granule.

Patients in this arm will receive placebo Bufei Jianpi granule.

Outcomes

Primary Outcome Measures

FEV1

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

Frequency of acute exacerbation

Frequency of acute exacerbation will be recorded.

Secondary Outcome Measures

Clinical symptom assessment questionnaire

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

mMRC

The modified Medical Research Council dyspnoea scale (mMRC) will be used to assess severity of dyspnea.

6MWD

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

CAT

The COPD assessment test (CAT) is a self-administered questionnaire that measures health-related 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.

EQ-5D

EuroQol 5D (EQ-5D) will be used to assess quality of life.

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

NCT03976700

First Posted

May 29, 2019

Last Updated

June 5, 2019

Sponsor

Henan University of Traditional Chinese Medicine

Collaborators

Jiangsu Province Hospital of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT03976700

Brief Title

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

Official Title

Bufei Jianpi Granule for Delaying Pulmonary Function Decline in Early-Stage 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 2021 (Anticipated)

Study Completion Date

December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Henan University of Traditional Chinese Medicine

Collaborators

Jiangsu Province Hospital of Traditional Chinese Medicine

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 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.

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 Jianpi 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

612 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bufei Jianpi granule

Arm Type

Experimental

Arm Description

Patients in this arm will receive Bufei Jianpi granule.

Arm Title

Placebo Bufei Jianpi granule

Arm Type

Placebo Comparator

Arm Description

Patients in this arm will receive placebo Bufei Jianpi granule.

Intervention Type

Drug

Intervention Name(s)

Bufei Jianpi granule

Intervention Description

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

Intervention Name(s)

Placebo Bufei Jianpi granule

Intervention Description

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.

Primary Outcome Measure Information:

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, 52, 78 and 104.

Title

Frequency of acute exacerbation

Description

Frequency of acute exacerbation will be recorded.

Time Frame

Up to week 104.

Secondary Outcome Measure Information:

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, 52, 65, 78, 91 and 104.

Title

mMRC

Description

The modified Medical Research Council dyspnoea scale (mMRC) will be used to assess severity of dyspnea.

Time Frame

Change from baseline mMRC scores at week 13, 26, 39, 52, 65, 78, 91 and 104.

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, 52, 65, 78, 91 and 104.

Title

CAT

Description

The COPD assessment test (CAT) is a self-administered questionnaire that measures health-related quality of life.

Time Frame

Change from baseline CAT scores at week 13, 26, 39, 52, 65, 78, 91 and 104.

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, 52, 65, 78, 91 and 104.

Title

mCOPD-PRO

Description

Time Frame

Change from baseline mCOPD-PRO scores at week 13, 26, 39, 52, 65, 78, 91 and 104.

Title

EQ-5D

Description

EuroQol 5D (EQ-5D) will be used to assess quality of life.

Time Frame

Change from baseline EQ-5D scores at week 13, 26, 39, 52, 65, 78, 91 and 104.

Title

mESQ-COPD

Description

Time Frame

Change from baseline mESQ-COPD scores at week 13, 26, 39, 52, 65, 78, 91 and 104.

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 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.

Central Contact Person:

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

Suyun Li, Professor

Phone

86-371-66248624

lisuyun2000@126.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

Suyun Li, Professor

Phone

86-371-66248624

lisuyun2000@126.com

12. IPD Sharing Statement

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

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