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Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Xuebijing
Placebo
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Xuebijing

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Body weight≥40kg and ≤100kg
  2. Diagnosis of COPD :(following Global initiative for Chronic Obstructive Lung Disease,GOLD2016)
  3. Forced Expiratory Volume in 1 second of less than 70% predicted value after bronchodilator
  4. 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.
  5. 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;
  6. sign the informed consent

Exclusion Criteria:

  1. Pregnant women, lactating women;
  2. Be allergic to Xuebijing;
  3. Acute exacerbation of COPD onset of more than 72 hours;
  4. AECOPD with severe hypoxemia:oxygenation index <150 or received Endotracheal intubation invasive mechanical ventilation;
  5. Participation in another experimental protocol within 30 days of study entry
  6. Primary diseases:Asthma,Cystic fibrosis,Lung cancer,Tuberculosis,Pulmonary sarcoidosis,Pulmonary interstitial fibrosis,Malignant neoplasms,Blood system diseases,HIV;
  7. Complications:Pulmonary embolism,shock,DIC,Unstable cardiovascular disease,Upper gastrointestinal bleeding,pneumothorax,Severe liver and kidney dysfunction;
  8. Mental incompetence or active psychiatric illness
  9. used the following drugs within 72 hours days of study entry:Ulinastatin,Tanreqing, Reduning,Qingkailing;
  10. 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.

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Xuebijing

Placebo

Arm Description

Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days

Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days

Outcomes

Primary Outcome Measures

Invasive mechanical ventilation rate
Invasive mechanical ventilation rate in %

Secondary Outcome Measures

length of Hospital stay
Invasive mechanical ventilation rate in days

Full Information

First Posted
October 13, 2016
Last Updated
October 18, 2016
Sponsor
Chinese PLA General Hospital
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
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1. Study Identification

Unique Protocol Identification Number
NCT02937974
Brief Title
Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD
Official Title
Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD:a Multicentre Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary Disease, Chronic Obstructive, Xuebijing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
254 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Xuebijing
Arm Type
Experimental
Arm Description
Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days
Intervention Type
Drug
Intervention Name(s)
Xuebijing
Intervention Description
Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days
Primary Outcome Measure Information:
Title
Invasive mechanical ventilation rate
Description
Invasive mechanical ventilation rate in %
Time Frame
28 days
Secondary Outcome Measure Information:
Title
length of Hospital stay
Description
Invasive mechanical ventilation rate in days
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lixin Xie, Professor
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19729666
Citation
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.
Results Reference
background
PubMed Identifier
30777117
Citation
Xie 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.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=19729666
Description
19729666

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Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD

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