Chronic Obstructive Pulmonary DiseasePhase 3NCT04208581
Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure
A Phase 3 study testing Yiqi Huoxue Huatan granule in people with Chronic Obstructive Pulmonary Disease and Chronic Respiratory Failure, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study aims to establish the treatment scheme of Yiqi Huoxue Huatan granule for chronic obstructive pulmonary disease (COPD) with chronic respiratory failure (CRF), reducing mortality, improving quality of life 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, Chronic Respiratory Failure
- What is being tested?
- Yiqi Huoxue Huatan granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 372 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 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 stable COPD;
- Arterial blood gas analysis meets criteria of PaO2 < 60mmHg and PaCO2 > 50mmHg during quiet breathing at sea level;
- Syndrome differentiation meets criteria of Qi deficiency, blood stasis and phlegm turbidity obstructing orifice syndrome；
- Age ranges from 40 years to 80 years;
- With informed consent signed.
Who cannot join
- • CRF resulting from other respiratory diseases, such as bronchiectasis, pulmonary cystic fibrosis, lung cancer, etc.;
- Acute exacerbation of CRF；
- Patients with severe cardiovascular and cerebrovascular diseases;
- Pregnant and lactating women;
- Patients with psychiatric disorders；
- Patients with diabetes;
- Patients who have participated in other clinical studies in the past 4 weeks;
- Patients who have experienced one or more acute exacerbation of COPD in the past 4 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure: A Randomized, Double-blind, Placebo Controlled Trial
This study aims to establish the treatment scheme of Yiqi Huoxue Huatan granule for chronic obstructive pulmonary disease (COPD) with chronic respiratory failure (CRF), reducing mortality, improving quality of life 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. COPD complicated by CRF is serious and has a high mortality rate. At present, ideal and effective treatment is inadequate. Traditional Chinese medicine (TCM) has some potential in improving outcomes in COPD with CRF.
This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of Yiqi Huoxue Huatan granule on reducing mortality and improving quality of life in COPD with CRF. After a 14-day run-in period, 372 subjects will be randomly assigned to treatment group or control group for 52-week treatment, followed by 52-week follow-up. The primary outcomes are all-cause mortality and frequency of acute exacerbation of COPD. The secondary outcomes include clinical symptoms, COPD assessment test (CAT), arterial blood gas analysis, pulmonary function and duration of mechanical ventilation. Safety will also be assessed.
- Being tested
- Yiqi Huoxue Huatan granule, Placebo Yiqi Huoxue Huatan granule
- Keywords
- Chronic Obstructive Pulmonary Disease, Chronic Respiratory Failure, Yiqi Huoxue Huatan Granule
- 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.
Yiqi Huoxue Huatan granuleDrug
Also called Tiotropium Bromide Powder for Inhalation, Salmeterol / Fluticasone Powder for Inhalation or Budesonide / Formoterol Powder for Inhalation
Yiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks.
Placebo Yiqi Huoxue Huatan granuleDrug
Also called Tiotropium Bromide Powder for Inhalation, Salmeterol / Fluticasone Powder for Inhalation or Budesonide / Formoterol Powder for Inhalation
Placebo Yiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Yiqi Huoxue Huatan granule plus Western medicine | Experimental | Patients in this arm will receive Yiqi Huoxue Huatan granule in addition to Western medicine. Receives: Drug: Yiqi Huoxue Huatan granule |
| Placebo Yiqi Huoxue Huatan granule plus Western medicine | Placebo comparator | Patients in this arm will receive placebo Yiqi Huoxue Huatan granule in addition to Western medicine. Receives: Drug: Placebo Yiqi Huoxue Huatan granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
All-cause mortality will be calculated in this study.
Measured: Up to week 52 of the follow-up phase.
Frequency of acute exacerbation of COPD
Frequency of acute exacerbation of COPD will be recorded.
Measured: Up to week 52 of the follow-up phase.
Secondary outcomes (7)
Clinical symptom assessment questionnaire
Clinical symptom assessment questionnaire of COPD will be used to assess symptoms.
Measured: Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
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 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
Arterial partial pressure of oxygen (PaO2)
PaO2 will be evaluated by arterial blood gas analysis.
Measured: Change from baseline PaO2 at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
Arterial partial pressure of carbon dioxide (PaCO2)
PaCO2 will be evaluated by arterial blood gas analysis.
Measured: Change from baseline PaCO2 at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
FEV1
Forced expiratory volume in one second ( FEV1) will be used to assess pulmonary function.
Measured: Change from baseline FEV1 at week 52 of the treatment phase, and week 52 of the follow-up phase.
Duration of mechanical ventilation
The duration of mechanical ventilation will be recorded.
Measured: Change from baseline duration of mechanical ventilation at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
Health economics
Cost of the treatment phase and follow-up phase will be recorded
Measured: Up to week 52 of the follow-up phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2019
- Study start8 Oct 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (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.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- 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
- 372 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Fengcuiling, Peking University People's Hospital
- Investigators
- Suyun Li, Doctor, Study chair, The First Affiliated Hospital of Henan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04208581
- Sponsor's protocol ID
- TCM for COPD with CRF
- Status last verified
- Jan 2020
- First submitted
- 20 Dec 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang JY, Wang HT, Zhao KM, Yu XQ, Huang DH, Wang HX, Wei GS, Bai L, Hou YJ, Huang QT, Hu J, Zhu HZ, Wu L, Lu XC, Chen YF, Gao F, Su LH, Wang Y, Li CY, Li SY, Feng CL. The efficacy and safety of Yiqi Huoxue Huatan granule in the treatment of stable COPD with chronic respiratory failure: A randomized, double-blind, placebo controlled trial. J Ethnopharmacol. 2025 Aug 29;352:120228. doi: 10.1016/j.jep.2025.120228. Epub 2025 Jul 1.
PubMed 40609812
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure: A Randomized, Double-blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT04208581
- Acronym / sponsor ID
- TCM for COPD with CRF
- Keywords
- Chronic Obstructive Pulmonary Disease, Chronic Respiratory Failure, Yiqi Huoxue Huatan Granule
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 372 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
- Study start
- 8 Oct 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Dec 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 Yiqi Huoxue Huatan granule for chronic obstructive pulmonary disease (COPD) with chronic respiratory failure (CRF), reducing mortality, improving quality of life 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. COPD complicated by CRF is serious and has a high mortality rate. At present, ideal and effective treatment is inadequate. Traditional Chinese medicine (TCM) has some potential in improving outcomes in COPD with CRF.
This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect of Yiqi Huoxue Huatan granule on reducing mortality and improving quality of life in COPD with CRF. After a 14-day run-in period, 372 subjects will be randomly assigned to treatment group or control group for 52-week treatment, followed by 52-week follow-up. The primary outcomes are all-cause mortality and frequency of acute exacerbation of COPD. The secondary outcomes include clinical symptoms, COPD assessment test (CAT), arterial blood gas analysis, pulmonary function and duration of mechanical ventilation. 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 |
|---|---|---|
| Yiqi Huoxue Huatan granule plus Western medicine | Experimental | Drug: Yiqi Huoxue Huatan granulePatients in this arm will receive Yiqi Huoxue Huatan granule in addition to Western medicine. |
| Placebo Yiqi Huoxue Huatan granule plus Western medicine | Placebo comparator | Drug: Placebo Yiqi Huoxue Huatan granulePatients in this arm will receive placebo Yiqi Huoxue Huatan 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 (5 listed)
- A confirmed diagnosis of stable COPD;
Key exclusion criteria (8 listed)
- • CRF resulting from other respiratory diseases, such as bronchiectasis, pulmonary cystic fibrosis, lung cancer, etc.;
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 |
|---|---|---|
| Yiqi Huoxue Huatan granuleAlso: Tiotropium Bromide Powder for Inhalation, Salmeterol / Fluticasone Powder for Inhalation or Budesonide / Formoterol Powder for InhalationYiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks. | Drug | Yiqi Huoxue Huatan granule plus Western medicine |
| Placebo Yiqi Huoxue Huatan granuleAlso: Tiotropium Bromide Powder for Inhalation, Salmeterol / Fluticasone Powder for Inhalation or Budesonide / Formoterol Powder for InhalationPlacebo Yiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks. | Drug | Placebo Yiqi Huoxue Huatan granule plus Western medicine |
Primary outcome
All-cause mortality
Time frame: Up to week 52 of the follow-up phase.
All-cause mortality will be calculated in this study.
Frequency of acute exacerbation of COPD
Time frame: Up to week 52 of the follow-up phase.
Frequency of acute exacerbation of COPD will be recorded.
7 secondary outcomes
Clinical symptom assessment questionnaire
Time frame: Change from baseline clinical symptom assessment questionnaire scores at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
CAT
Time frame: Change from baseline CAT scores at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
Arterial partial pressure of oxygen (PaO2)
Time frame: Change from baseline PaO2 at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
Arterial partial pressure of carbon dioxide (PaCO2)
Time frame: Change from baseline PaCO2 at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
FEV1
Time frame: Change from baseline FEV1 at week 52 of the treatment phase, and week 52 of the follow-up phase.
Duration of mechanical ventilation
Time frame: Change from baseline duration of mechanical ventilation at week 13, 26, 39 and 52 of the treatment phase, and week 13, 26, 39 and 52 of the follow-up phase.
Health economics
Time frame: Up to week 52 of the follow-up phase.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Derived from this study: PubMed 40609812Yang JY, Wang HT, Zhao KM, Yu XQ, Huang DH, Wang HX, Wei GS, Bai L, Hou YJ, Huang QT, Hu J, Zhu HZ, Wu L, Lu XC, Chen YF, Gao F, Su LH, Wang Y, Li CY, Li SY, Feng CL. The efficacy and safety of Yiqi Huoxue Huatan granule in the treatment of stable COPD with chronic respiratory failure: A randomized, double-blind, placebo controlled trial. J Ethnopharmacol. 2025 Aug 29;352:120228. doi: 10.1016/j.jep.2025.120228. Epub 2025 Jul 1.
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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.
Suyun Li, Doctor study chair
The First Affiliated Hospital of Henan University of 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 Yiqi Huoxue Huatan granule in people with Chronic Obstructive Pulmonary Disease and Chronic Respiratory Failure, run by Peking University People's Hospital 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 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 7 Jan 2020. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: Up to week 52 of the follow-up phase.). 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 NCT04208581, 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 7 Jan 2020.