Combined Pulmonary Fibrosis and EmphysemaPhase 2NCT02805699
A Clinical Evaluation of Baofeikang Granule in Combined Pulmonary Fibrosis and Emphysema Treatment
A Phase 2 study testing Baofeikang Granule in people with Combined Pulmonary Fibrosis and Emphysema, run by Beijing Municipal Science & Technology Commission at 2 sites in China.
Trial summary
The purpose of this study is to confirm the efficacy and safety of BaofeiKang Granule in the treatment of Combined Pulmonary Fibrosis and Emphysema patients. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Combined Pulmonary Fibrosis and Emphysema
- What is being tested?
- Baofeikang Granule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- Jun 2016to Sep 2019
- Phase
- Phase 2
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- conform to Combined Pulmonary Fibrosis and Emphysema Treatment diagnostic criteria;
- conform to Qi and yin deficiency, phlegm and blood stasis syndrome diagnosis standard;
- Patients with non acute episode;
- Age between 45-75 (including 45 and 75);
- signed the informed consent.
Who cannot join
- Combined upper and lower respiratory infection, pulmonary tuberculosis, lung cancer or other lung diseases;
- Combined with diabetes, cardiovascular, liver, kidney or hematopoietic system diseases, psychiatric patients;
- Pregnancy and lactation patients;
- Allergic to the subjects of the medicine.
- Rejection criteria:
- do not meet the inclusion criteria after entering the group;
- the discovery of serious physical illness after entering the group;
- do not follow the program medication of patients;
Trial locations and contacts
2 sites in 1 country.
chang'an Li, Master contact
China2 sites, 2 recruiting
- Recruiting
Beijing University of Chinese Medicine Third Affiliated Hospital
Beijing, Beijing Municipality, 100029
fei han, 010-52075251, kymbxz@126.com
changan li, 010-52075411, lichangan1989@163.com
- Recruiting
Dongzhimen hospital
Beijing, Beijing Municipality
Lishan Zhang, 010-52075411, lszh111@sina.com
About this study
Official title: Beijing Municipal Science and Technology Commission
The purpose of this study is to confirm the efficacy and safety of BaofeiKang Granule in the treatment of Combined Pulmonary Fibrosis and Emphysema patients.
Read the detailed description
A randomized, double blinded, placebo controlled study is conducted to observe the efficacy and safety of BaoFeiKang Granule in the treatment of patients with Combined Pulmonary Fibrosis and Emphysema. The Traditional Chinese Medicine（TCM） syndrome intergal,lung function ,Chronic Obstructive Pulmonary Disease Assessment Test（CAT）score, acute exacerbation, arterial blood gas analysis, chest High Resolution Computerized Tomography （HRCT）and liver and kidney function are to be calculated and tested before and after the trial.
- Randomization All the selected cases is divided into the experimental group and the control group randomly, and the section size is 6. STATISTICAL ANALYSIS SYSTEM（SAS）statistical software are randomly assigned table，and clinical researchers given the corresponding code number to the selected qualified patients.According to the code number,patients receive the corresponding code number box.The persons who generate and preserve of tables are not involved in clinical trials.
- Drug coding According to the protocol,the experimental duration of treatment is 3 months.The patients accept the medication for each month.
- Blind method In the course of the study, the researchers and the subjects were not aware of the grouping of the research objects.
- Sample size According to the formula,n=(Uα+Uβ)2*2P(1-P)/(P1-P0),the required sample size of each group is calculated.P1 represents for the efficiency of treatment group, P0 for the control group, P= (P1+P0) /2 * 100%;α＝0.05，β＝0.10，Uα=1.65，Uβ=1.28.According to the previous research results and literature research,P1=70%,P0=40%.It is calculated n = 47,and considering shedding rate of 20%,n =56.So actual each group includes 60 patients.
- Implementation and management (1) training of 4 clinical researchers to master case collection methods and evaluation methods to minimize selection bias; (2) all experimental drugs are used in the same batch of drugs. (3) to collect data of the combination of medication and the treatment to exclude the impact of the above interference; (4) inform patients to get a more comprehensive evaluation and follow-up treatment.Special problems can get all respiratory department doctor's consultation, so as to achieve patient cooperation and understanding.(5)List the cases of loss or withdrawal, and specify the details and reasons.
- Being tested
- Baofeikang Granule, Placebo
- Keywords
- Clinical Efficacy, Baofeikang Granules, Combined Pulmonary Fibrosis and Emphysema
- Medical subject headings
- Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baofeikang GranuleDrug
Also called Treatment Group
To observe the efficacy and safety of Baofeikang granules on Combined Pulmonary Fibrosis and Emphysema Treatment.Baofeikang Granules consist of（Codonopsis 30g, Cordyceps fungi powder 12g, ophiopogon root 10g, Schisandra 10g, angelica 15g, Bulbus Fritillariae thunbergii 10g, Sophora flavescens 10g,Forsythia suspensa 12g，Pinellia 10g, saponins thorn 10g, Radix Peucedani 10g）.1 bags,P.O（Oral）twice of each 3 months cycle.
PlaceboDrug
Also called Control Group
On the basis of comprehensive treatment of spasmolysis antiasthmatic and anti-inflammatory, expectorant, cough ， give Chinese medicine placebo,1 bags,P.O（Oral）twice of each 3 months cycle.
| Study group | Role | What they receive |
|---|---|---|
| Baofeikang Granule | Experimental | On the basis of comprehensive treatment of spasmolysis antiasthmatic and anti-inflammatory, expectorant,cough,give BaoFeikang Granules(by Beijing KangRentang Pharmaceutical Co., Ltd.), 1 bag, twice each day. Receives: Drug: Baofeikang Granule |
| Placebo | Placebo comparator | On the basis of comprehensive treatment of spasmolysis antiasthmatic and anti-inflammatory, expectorant,coughand give Chinese medicine placebo (by Beijing Kang Rentang Pharmaceutical Co., Ltd., requirements and Chinese medicine BaoFeikang Granules in appearance and taste similar),1bag，twice each day. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in the efficacy of TCM syndrome index at 3 months
Observe the changes of the symptoms of wheezing, chest congestion, cough, shortness of breath and etc
Measured: Baseline and 3 months after the start of treatment
Secondary outcomes (8)
Changes from baselines in Chronic Obstructive Pulmonary Disease Assessment Test(CAT)at 3 months
Measured: Baseline and 3 months after the start of treatment
Changes from baselines in Arterial blood gas analysis(ABG)at 3 months
Measured: Baseline and 3 months after the start of treatment
The scope and degree of fibrosis and emphysema of pulmonary in chest High Resolution Computerized Tomography(HRCT)
Measured: Baseline and 3 months after the start of treatment
Changes from baselines in frequence of acute exacerbation of cough,sputum,dyspnea at 1,2,3 months
acute exacerbation defined as involving symptoms lasting for >2 days , leading to treatment with systemic glucocorticoids, antibiotics, hospitalization or emergency
Measured: Baseline and 1，2，3 months after the start of treatment
Forced Expiratory Volume in one second(FEV1)
pulmonary function
Measured: Baseline and 3 months after the start of treatment
Forced Vital Capacity(FVC)
pulmonary function
Measured: Baseline and 3 months after the start of treatment
Total Lung Capacity(TLC)
pulmonary function
Measured: Baseline and 3 months after the start of treatment
Diffusion capacity for Carbon monoxide of the Lung(DLCO)
pulmonary function
Measured: Baseline and 3 months after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined Pulmonary Fibrosis and EmphysemaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Municipal Science & Technology Commission
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cui Hongsheng, Beijing Municipal Science & Technology Commission
- Investigators
- hongsheng cui, Ph.D，Professor, Study chair, The Third Affiliated Hospital of Beijing University of Chinese Medicineweibo Bi, Master, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese Medicinejianjun Wu, Master, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese Medicineruifeng Jin, Master, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese Medicinechang'an Li, Master, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese Medicineminmin Shan, Master, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese Medicineqiuyi Chen, Bachelor, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese Medicineshengtao li, Bachelor, Principal investigator, The Third Affiliated Hospital of Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02805699
- Sponsor's protocol ID
- Z161100000516055
- Status last verified
- Aug 2017
- First submitted
- 6 Jun 2016
- Last updated
- 30 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beijing Municipal Science and Technology Commission
- ClinicalTrials.gov ID
- NCT02805699
- Acronym / sponsor ID
- Z161100000516055
- Keywords
- Clinical Efficacy, Baofeikang Granules, Combined Pulmonary Fibrosis and Emphysema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Beijing Municipal Science & Technology CommissionUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 20 Jun 2016 (estimated)
- 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.
The purpose of this study is to confirm the efficacy and safety of BaofeiKang Granule in the treatment of Combined Pulmonary Fibrosis and Emphysema patients.
Detailed description
A randomized, double blinded, placebo controlled study is conducted to observe the efficacy and safety of BaoFeiKang Granule in the treatment of patients with Combined Pulmonary Fibrosis and Emphysema. The Traditional Chinese Medicine（TCM） syndrome intergal,lung function ,Chronic Obstructive Pulmonary Disease Assessment Test（CAT）score, acute exacerbation, arterial blood gas analysis, chest High Resolution Computerized Tomography （HRCT）and liver and kidney function are to be calculated and tested before and after the trial.
- Randomization All the selected cases is divided into the experimental group and the control group randomly, and the section size is 6. STATISTICAL ANALYSIS SYSTEM（SAS）statistical software are randomly assigned table，and clinical researchers given the corresponding code number to the selected qualified patients.According to the code number,patients receive the corresponding code number box.The persons who generate and preserve of tables are not involved in clinical trials.
- Drug coding According to the protocol,the experimental duration of treatment is 3 months.The patients accept the medication for each month.
- Blind method In the course of the study, the researchers and the subjects were not aware of the grouping of the research objects.
- Sample size According to the formula,n=(Uα+Uβ)2*2P(1-P)/(P1-P0),the required sample size of each group is calculated.P1 represents for the efficiency of treatment group, P0 for the control group, P= (P1+P0) /2 * 100%;α＝0.05，β＝0.10，Uα=1.65，Uβ=1.28.According to the previous research results and literature research,P1=70%,P0=40%.It is calculated n = 47,and considering shedding rate of 20%,n =56.So actual each group includes 60 patients.
- Implementation and management (1) training of 4 clinical researchers to master case collection methods and evaluation methods to minimize selection bias; (2) all experimental drugs are used in the same batch of drugs. (3) to collect data of the combination of medication and the treatment to exclude the impact of the above interference; (4) inform patients to get a more comprehensive evaluation and follow-up treatment.Special problems can get all respiratory department doctor's consultation, so as to achieve patient cooperation and understanding.(5)List the cases of loss or withdrawal, and specify the details and reasons.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baofeikang Granule | Experimental | Drug: Baofeikang GranuleOn the basis of comprehensive treatment of spasmolysis antiasthmatic and anti-inflammatory, expectorant,cough,give BaoFeikang Granules(by Beijing KangRentang Pharmaceutical Co., Ltd.), 1 bag, twice each day. |
| Placebo | Placebo comparator | Drug: PlaceboOn the basis of comprehensive treatment of spasmolysis antiasthmatic and anti-inflammatory, expectorant,coughand give Chinese medicine placebo (by Beijing Kang Rentang Pharmaceutical Co., Ltd., requirements and Chinese medicine BaoFeikang Granules in appearance and taste similar),1bag，twice each day. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- conform to Combined Pulmonary Fibrosis and Emphysema Treatment diagnostic criteria;
- conform to Qi and yin deficiency, phlegm and blood stasis syndrome diagnosis standard;
- Patients with non acute episode;
- Age between 45-75 (including 45 and 75);
- signed the informed consent.
Key exclusion criteria (8 listed)
- Combined upper and lower respiratory infection, pulmonary tuberculosis, lung cancer or other lung diseases;
- Combined with diabetes, cardiovascular, liver, kidney or hematopoietic system diseases, psychiatric patients;
- Pregnancy and lactation patients;
- Allergic to the subjects of the medicine.
- do not meet the inclusion criteria after entering the group;
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 |
|---|---|---|
| Baofeikang GranuleAlso: Treatment GroupTo observe the efficacy and safety of Baofeikang granules on Combined Pulmonary Fibrosis and Emphysema Treatment.Baofeikang Granules consist of（Codonopsis 30g, Cordyceps fungi powder 12g, ophiopogon root 10g, Schisandra 10g, angelica 15g, Bulbus Fritillariae thunbergii 10g, Sophora flavescens 10g,Forsythia suspensa 12g，Pinellia 10g, saponins thorn 10g, Radix Peucedani 10g）.1 bags,P.O（Oral）twice of each 3 months cycle. | Drug | Baofeikang Granule |
| PlaceboAlso: Control GroupOn the basis of comprehensive treatment of spasmolysis antiasthmatic and anti-inflammatory, expectorant, cough ， give Chinese medicine placebo,1 bags,P.O（Oral）twice of each 3 months cycle. | Drug | Placebo |
Primary outcome
Changes from baseline in the efficacy of TCM syndrome index at 3 months
Time frame: Baseline and 3 months after the start of treatment
Observe the changes of the symptoms of wheezing, chest congestion, cough, shortness of breath and etc
8 secondary outcomes
Changes from baselines in Chronic Obstructive Pulmonary Disease Assessment Test(CAT)at 3 months
Time frame: Baseline and 3 months after the start of treatment
Changes from baselines in Arterial blood gas analysis(ABG)at 3 months
Time frame: Baseline and 3 months after the start of treatment
The scope and degree of fibrosis and emphysema of pulmonary in chest High Resolution Computerized Tomography(HRCT)
Time frame: Baseline and 3 months after the start of treatment
Changes from baselines in frequence of acute exacerbation of cough,sputum,dyspnea at 1,2,3 months
Time frame: Baseline and 1，2，3 months after the start of treatment
Forced Expiratory Volume in one second(FEV1)
Time frame: Baseline and 3 months after the start of treatment
Forced Vital Capacity(FVC)
Time frame: Baseline and 3 months after the start of treatment
Total Lung Capacity(TLC)
Time frame: Baseline and 3 months after the start of treatment
Diffusion capacity for Carbon monoxide of the Lung(DLCO)
Time frame: Baseline and 3 months after the start of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2017.
- Individual participant dataSharing planned: Yes
Related trials for Combined Pulmonary Fibrosis and Emphysema
RecruitingPhase 1/2
Lung and Bone Marrow Transplantation for Lung and Bone Marrow Failure
Idiopathic Pulmonary Fibrosis, Emphysema or COPD
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.
chang'an Li, Master contact
hongsheng cui, Ph.D，Professor study chair
The Third Affiliated Hospital of Beijing University of Chinese Medicine
weibo Bi, Master principal investigator
The Third Affiliated Hospital of Beijing University of Chinese Medicine
jianjun Wu, Master principal investigator
The Third Affiliated Hospital of Beijing University of Chinese Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Baofeikang Granule in people with Combined Pulmonary Fibrosis and Emphysema, run by Beijing Municipal Science & Technology Commission at 2 sites 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 5 inclusion and 8 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 30 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 hongsheng Cui, Ph.D，Professor (010-54075410, hshcui@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in the efficacy of TCM syndrome index at 3 months (time frame: Baseline and 3 months after the start of treatment). 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 30 Aug 2017.