Pulmonary Disease, Chronic ObstructivePhase 4NCT02937974
Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD
A Phase 4 study testing Xuebijing in people with Pulmonary Disease, Chronic Obstructive, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Objective: A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD). Methods: 254 AECOPD inpatients will be recruited in 6 hospitals in China over 2 years. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Xuebijing
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Dec 2018
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body weight≥40kg and ≤100kg
- Diagnosis of COPD :(following Global initiative for Chronic Obstructive Lung Disease，GOLD2016)
- Forced Expiratory Volume in 1 second of less than 70% predicted value after bronchodilator
- Acute exacerbation of COPD: the clinical presentation of the patient complaining of an acute change of symptoms(baseline dyspnea,cough,and/or sputum production)that is beyond normal day-to-day variation.
- Assessment of COPD Exacerbations: Medical History:severity of COPD based on degree of airflow limitation;Duration of worsening or new symptoms;Number of previous episodes (total/hospitalizations); Comorbidities; Present treatment regimen;Previous use of mechanical ventilation;
- sign the informed consent
Who cannot join
- Pregnant women, lactating women；
- Be allergic to Xuebijing；
- Acute exacerbation of COPD onset of more than 72 hours；
- AECOPD with severe hypoxemia：oxygenation index <150 or received Endotracheal intubation invasive mechanical ventilation；
- Participation in another experimental protocol within 30 days of study entry
- Primary diseases：Asthma，Cystic fibrosis，Lung cancer，Tuberculosis，Pulmonary sarcoidosis，Pulmonary interstitial fibrosis，Malignant neoplasms，Blood system diseases，HIV；
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- Complications：Pulmonary embolism，shock，DIC，Unstable cardiovascular disease，Upper gastrointestinal bleeding，pneumothorax，Severe liver and kidney dysfunction；
- Mental incompetence or active psychiatric illness
- used the following drugs within 72 hours days of study entry：Ulinastatin，Tanreqing， Reduning，Qingkailing；
- The investigator judged that the subject could not be completed or should not participate in the trial：Hemodialysis more than 1 mouth，Organ transplant patients with potential medical dispute.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD：a Multicentre Randomised Controlled Trial
Objective: A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD).
Methods: 254 AECOPD inpatients will be recruited in 6 hospitals in China over 2 years. They will be randomly assigned to Experimental group and Placebo group，Experimental: Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days；Placebo Comparator: Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days. Compare the following index between the two groups: Invasive mechanical ventilation rate, length of hospital stay, Treg cell,Th1,Th2,HLA-DR,CRP,PCT,IL-4,IL-6,IL-10,TNF-α，IFN-γ, APACHEⅡ, CAPS score.
Read the detailed description
A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Xuebijing, Placebo
- Keywords
- Pulmonary Disease, Chronic Obstructive, Xuebijing
- 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.
XuebijingDrug
Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days
PlaceboDrug
Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days
| Study group | Role | What they receive |
|---|---|---|
| Xuebijing | Experimental | Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days Receives: Drug: Xuebijing |
| Placebo | Placebo comparator | Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive mechanical ventilation rate
Invasive mechanical ventilation rate in %
Measured: 28 days
Secondary outcomes (1)
length of Hospital stay
Invasive mechanical ventilation rate in days
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospitals affiliated to the China PLA General Hospital, Navy General Hospital, Beijing, Rocket Force General Hospital，Chinese People's Liberation Army, 307 Hospital of PLA, Beijing Shijitan Hospital, Capital Medical University
- Responsible party
- Principal investigator, Lixin Xie, Chinese PLA General Hospital
- Investigators
- Lixin Xie, Professor, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937974
- Sponsor's protocol ID
- WK-2016-HR-02
- Other IDs
- Chinese PLA General Hospital
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2016
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Freeman CM, Martinez FJ, Han MK, Ames TM, Chensue SW, Todt JC, Arenberg DA, Meldrum CA, Getty C, McCloskey L, Curtis JL. Lung dendritic cell expression of maturation molecules increases with worsening chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Dec 15;180(12):1179-88. doi: 10.1164/rccm.200904-0552OC. Epub 2009 Sep 3.
PubMed 19729666Xie S, Yan P, Yao C, Yan X, Huo Y, Zhang J, Liu S, Feng Z, Shang H, Xie L. Efficacy and safety of Xuebijing injection and its influence on immunomodulation in acute exacerbations of chronic obstructive pulmonary disease: study protocol for a randomized controlled trial. Trials. 2019 Feb 18;20(1):136. doi: 10.1186/s13063-019-3204-z.
PubMed 30777117
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD：a Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02937974
- Acronym / sponsor ID
- WK-2016-HR-02
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Xuebijing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- First Hospitals affiliated to the China PLA General Hospital, Navy General Hospital, Beijing, Rocket Force General Hospital，Chinese People's Liberation Army, 307 Hospital of PLA, Beijing Shijitan Hospital, Capital Medical University
- Study start
- Oct 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 19 Oct 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.
Objective: A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD).
Methods: 254 AECOPD inpatients will be recruited in 6 hospitals in China over 2 years. They will be randomly assigned to Experimental group and Placebo group，Experimental: Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days；Placebo Comparator: Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days. Compare the following index between the two groups: Invasive mechanical ventilation rate, length of hospital stay, Treg cell,Th1,Th2,HLA-DR,CRP,PCT,IL-4,IL-6,IL-10,TNF-α，IFN-γ, APACHEⅡ, CAPS score.
Detailed description
A prospective multicenter randomized controlled trial to assess the efficacy and safety of Xuebijing injection for acute exacerbation of chronic obstructive pulmonary disease(AECOPD).
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 |
|---|---|---|
| Xuebijing | Experimental | Drug: XuebijingXuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days |
| Placebo | Placebo comparator | Drug: PlaceboNormal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Body weight≥40kg and ≤100kg
- Diagnosis of COPD :(following Global initiative for Chronic Obstructive Lung Disease，GOLD2016)
- Forced Expiratory Volume in 1 second of less than 70% predicted value after bronchodilator
- Acute exacerbation of COPD: the clinical presentation of the patient complaining of an acute change of symptoms(baseline dyspnea,cough,and/or sputum production)that is beyond normal day-to-day variation.
- Assessment of COPD Exacerbations: Medical History:severity of COPD based on degree of airflow limitation;Duration of worsening or new symptoms;Number of previous episodes (total/hospitalizations); Comorbidities; Present treatment regimen;Previous use of mechanical ventilation;
Key exclusion criteria (10 listed)
- Pregnant women, lactating women；
- Be allergic to Xuebijing；
- Acute exacerbation of COPD onset of more than 72 hours；
- AECOPD with severe hypoxemia：oxygenation index <150 or received Endotracheal intubation invasive mechanical ventilation；
- Participation in another experimental protocol within 30 days of study entry
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 |
|---|---|---|
| XuebijingXuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days | Drug | Xuebijing |
| PlaceboNormal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days | Drug | Placebo |
Primary outcome
Invasive mechanical ventilation rate
Time frame: 28 days
Invasive mechanical ventilation rate in %
1 secondary outcome
length of Hospital stay
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Background: PubMed 19729666Freeman CM, Martinez FJ, Han MK, Ames TM, Chensue SW, Todt JC, Arenberg DA, Meldrum CA, Getty C, McCloskey L, Curtis JL. Lung dendritic cell expression of maturation molecules increases with worsening chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009 Dec 15;180(12):1179-88. doi: 10.1164/rccm.200904-0552OC. Epub 2009 Sep 3.
- Derived from this study: PubMed 30777117Xie S, Yan P, Yao C, Yan X, Huo Y, Zhang J, Liu S, Feng Z, Shang H, Xie L. Efficacy and safety of Xuebijing injection and its influence on immunomodulation in acute exacerbations of chronic obstructive pulmonary disease: study protocol for a randomized controlled trial. Trials. 2019 Feb 18;20(1):136. doi: 10.1186/s13063-019-3204-z.
- 19729666Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Lixin Xie, Professor study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xuebijing in people with Pulmonary Disease, Chronic Obstructive, run by Chinese PLA General 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 6 inclusion and 10 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 19 Oct 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Invasive mechanical ventilation rate (time frame: 28 days). 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 NCT02937974, which also lists 2 linked publications.
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 19 Oct 2016.