Chronic Obstructive Pulmonary DiseasePhase 3NCT03976713
Bufei Yishen Granule for Reducing Acute Exacerbation in GOLD Stage 3 or 4 COPD
A Phase 3 study testing Bufei Yishen granule and Tiotropium Bromide Powder for Inhalation in people with Chronic Obstructive Pulmonary Disease, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Bufei Yishen granule and Tiotropium Bromide Powder for Inhalation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 348 participants
- Where
- 1 siteChina
- Study dates
- Jun 2019to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
Xueqing Yu, Doctor, 86-371-66248624, yxqshi@163.com
About this study
Official title: Bufei Yishen Granule for Reducing Acute Exacerbation in GOLD Stage 3 or 4 COPD: A Randomized, Double-blind, Placebo Controlled Trial
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.
Read the 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
- Being tested
- Bufei Yishen granule, Placebo Bufei Yishen granule, Tiotropium Bromide Powder for Inhalation
- Keywords
- Chronic Obstructive Pulmonary Disease, Bufei Yishen Granule, Randomized Controlled Trial
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bufei Yishen granuleDrug
Bufei Yishen granule will be administered twice daily for five days a week for 52 weeks.
Placebo Bufei Yishen granuleDrug
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 InhalationDrug
Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Bufei Yishen granule plus Western medicine | Experimental | Patients in this arm will receive Bufei Yishen granule in addition to Western medicine. Receives: 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. Receives: Drug: Placebo Bufei Yishen granule; Drug: Tiotropium Bromide Powder for Inhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of acute exacerbation
Frequency of acute exacerbation will be recorded.
Measured: Up to week 52.
Duration of acute exacerbation
Duration of acute exacerbation will be recorded.
Measured: Up to week 52.
Secondary outcomes (8)
Mortality
The mortality will be calculated.
Measured: Up to week 52.
FEV1
Forced expiratory volume in one second ( FEV1) will be used to assess pulmonary function.
Measured: Change from baseline FEV1 at week 26 and 52.
Clinical symptom assessment questionnaire
Clinical symptom assessment questionnaire of COPD will be used to assess symptom.
Measured: Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39 and 52.
6MWD
Six-minute walk distance (6MWD) will be conducted to assess exercise capacity
Measured: Change from baseline 6MWD at week 13, 26, 39 and 52.
CAT
COPD assessment test (CAT) will be used to assess quality of life.
Measured: Change from baseline CAT scores at week 13, 26, 39 and 52.
SF-36
The MOS 36-Item Short-Form Health Survey (SF-36) will be used to assess quality of life.
Measured: Change from baseline SF-36 scores at week 13, 26, 39 and 52.
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.
Measured: Change from baseline mCOPD-PRO scores at week 13, 26, 39 and 52.
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.
Measured: Change from baseline mESQ-COPD scores at week 13, 26, 39 and 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study startJun 2019 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- ShuGuang Hospital
- Responsible party
- Sponsor
- Investigators
- Jiansheng Li, Professor, Study chair, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976713
- Sponsor's protocol ID
- TCM for GOLD stage 3 or 4 COPD
- Status last verified
- May 2019
- First submitted
- 29 May 2019
- Last updated
- 6 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37955027
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bufei Yishen Granule for Reducing Acute Exacerbation in GOLD Stage 3 or 4 COPD: A Randomized, Double-blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03976713
- Acronym / sponsor ID
- TCM for GOLD stage 3 or 4 COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Bufei Yishen Granule, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- ShuGuang Hospital
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 6 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bufei Yishen granule plus Western medicine | Experimental | Drug: Bufei Yishen granule, Drug: Tiotropium Bromide Powder for InhalationPatients in this arm will receive Bufei Yishen granule in addition to Western medicine. |
| Placebo Bufei Yishen granule plus Western medicine | Placebo comparator | Drug: Placebo Bufei Yishen granule, Drug: Tiotropium Bromide Powder for InhalationPatients in this arm will receive placebo Bufei Yishen granule in addition to Western medicine. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bufei Yishen granuleBufei Yishen granule will be administered twice daily for five days a week for 52 weeks. | Drug | Bufei Yishen granule plus Western medicine |
| Placebo Bufei Yishen granulePlacebo 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 | Placebo Bufei Yishen granule plus Western medicine |
| Tiotropium Bromide Powder for InhalationTiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks. | Drug | Bufei Yishen granule plus Western medicine, Placebo Bufei Yishen granule plus Western medicine |
Primary outcome
Frequency of acute exacerbation
Time frame: Up to week 52.
Frequency of acute exacerbation will be recorded.
Duration of acute exacerbation
Time frame: Up to week 52.
Duration of acute exacerbation will be recorded.
8 secondary outcomes
Mortality
Time frame: Up to week 52.
FEV1
Time frame: Change from baseline FEV1 at week 26 and 52.
Clinical symptom assessment questionnaire
Time frame: Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39 and 52.
6MWD
Time frame: Change from baseline 6MWD at week 13, 26, 39 and 52.
CAT
Time frame: Change from baseline CAT scores at week 13, 26, 39 and 52.
SF-36
Time frame: Change from baseline SF-36 scores at week 13, 26, 39 and 52.
mCOPD-PRO
Time frame: Change from baseline mCOPD-PRO scores at week 13, 26, 39 and 52.
mESQ-COPD
Time frame: Change from baseline mESQ-COPD scores at week 13, 26, 39 and 52.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2019.
- Derived from this study: PubMed 37955027Yu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiansheng Li, Professor study chair
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bufei Yishen granule and Tiotropium Bromide Powder for Inhalation in people with Chronic Obstructive Pulmonary Disease, run by Henan University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xueqing Yu, Doctor (86-371-66248624, yxqshi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of acute exacerbation (time frame: Up to week 52.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03976713, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2019.