Chronic Obstructive Pulmonary DiseasePhase 3NCT03976700
Bufei Jianpi Granule for Delaying Pulmonary Function Decline in Early-Stage COPD
A Phase 3 study testing Bufei Jianpi granule 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 Jianpi granule for early-stage (GOLD stage 1 or 2) chronic obstructive pulmonary disease (COPD), delaying pulmonary function decline 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 Jianpi granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 612 participants
- Where
- 1 siteChina
- Study dates
- Jun 2019to Dec 2021
- 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 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.
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 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.
- 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.
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
Suyun Li, Professor, 86-371-66248624, lisuyun2000@126.com
About this study
Official title: Bufei Jianpi Granule for Delaying Pulmonary Function Decline in Early-Stage COPD: A Randomized, Double-blind, Placebo Controlled Trial
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.
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. 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Bufei Jianpi granule, Placebo Bufei Jianpi granule
- Keywords
- Chronic Obstructive Pulmonary Disease, Bufei Jianpi 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 Jianpi granuleDrug
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.
Placebo Bufei Jianpi granuleDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Bufei Jianpi granule | Experimental | Patients in this arm will receive Bufei Jianpi granule. Receives: Drug: Bufei Jianpi granule |
| Placebo Bufei Jianpi granule | Placebo comparator | Patients in this arm will receive placebo Bufei Jianpi granule. Receives: Drug: Placebo Bufei Jianpi granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
FEV1
Forced expiratory volume in one second ( FEV1) will be used to assess pulmonary function.
Measured: Change from baseline FEV1 at week 26, 52, 78 and 104.
Frequency of acute exacerbation
Frequency of acute exacerbation will be recorded.
Measured: Up to week 104.
Secondary outcomes (8)
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, 52, 65, 78, 91 and 104.
mMRC
The modified Medical Research Council dyspnoea scale (mMRC) will be used to assess severity of dyspnea.
Measured: Change from baseline mMRC scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
6MWD
Six-minute walk distance (6MWD) will be conducted to assess exercise capacity.
Measured: Change from baseline 6MWD at week 13, 26, 39, 52, 65, 78, 91 and 104.
CAT
The COPD assessment test (CAT) is a self-administered questionnaire that measures health-related quality of life.
Measured: Change from baseline CAT scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
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, 52, 65, 78, 91 and 104.
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, 52, 65, 78, 91 and 104.
EQ-5D
EuroQol 5D (EQ-5D) will be used to assess quality of life.
Measured: Change from baseline EQ-5D scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
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, 52, 65, 78, 91 and 104.
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 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Province Hospital of Traditional Chinese Medicine
- 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
- NCT03976700
- Sponsor's protocol ID
- TCM for Early-Stage 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
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 Jianpi Granule for Delaying Pulmonary Function Decline in Early-Stage COPD: A Randomized, Double-blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03976700
- Acronym / sponsor ID
- TCM for Early-Stage COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic Obstructive Pulmonary Disease, Bufei Jianpi Granule, Randomized Controlled Trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 612 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Jiangsu Province Hospital of Traditional Chinese Medicine
- Study start
- Jun 2019 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Dec 2021 (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 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.
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 Jianpi granule | Experimental | Drug: Bufei Jianpi granulePatients in this arm will receive Bufei Jianpi granule. |
| Placebo Bufei Jianpi granule | Placebo comparator | Drug: Placebo Bufei Jianpi granulePatients in this arm will receive placebo Bufei Jianpi granule. |
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 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.
Key exclusion criteria (11 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 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 Jianpi granuleBufei 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. | Drug | Bufei Jianpi granule |
| Placebo Bufei Jianpi granulePlacebo 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. | Drug | Placebo Bufei Jianpi granule |
Primary outcome
FEV1
Time frame: Change from baseline FEV1 at week 26, 52, 78 and 104.
Forced expiratory volume in one second ( FEV1) will be used to assess pulmonary function.
Frequency of acute exacerbation
Time frame: Up to week 104.
Frequency of acute exacerbation will be recorded.
8 secondary outcomes
Clinical symptom assessment questionnaire
Time frame: Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
mMRC
Time frame: Change from baseline mMRC scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
6MWD
Time frame: Change from baseline 6MWD at week 13, 26, 39, 52, 65, 78, 91 and 104.
CAT
Time frame: Change from baseline CAT scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
SF-36
Time frame: Change from baseline SF-36 scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
mCOPD-PRO
Time frame: Change from baseline mCOPD-PRO scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
EQ-5D
Time frame: Change from baseline EQ-5D scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
mESQ-COPD
Time frame: Change from baseline mESQ-COPD scores at week 13, 26, 39, 52, 65, 78, 91 and 104.
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.
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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 Jianpi granule 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 11 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 Suyun Li, Professor (86-371-66248624, lisuyun2000@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 (time frame: Change from baseline FEV1 at week 26, 52, 78 and 104.). 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?
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.