Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD

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.

Study Overview

• Status: Unknown
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Xuebijing; Drug: Placebo

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 Type: Interventional
• Enrollment (Anticipated): 254
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100853
    • Chinese PLA General hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Xuebijing; Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days	Drug: Xuebijing; Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days
Placebo Comparator: Placebo; Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days	Drug: Placebo; Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive mechanical ventilation rate	Invasive mechanical ventilation rate in %	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of Hospital stay	Invasive mechanical ventilation rate in days	28 days

Collaborators and Investigators

• Sponsor: Chinese PLA General Hospital
• Collaborators: 307 Hospital of PLA; Beijing Shijitan Hospital, Capital Medical University; Navy General Hospital, Beijing; First Hospitals affiliated to the China PLA General Hospital; Rocket Force General Hospital，Chinese People's Liberation Army
• Investigators: Study Director: Lixin Xie, Professor, Chinese PLA General hospital

Publications and helpful links

General 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.
• 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.

Helpful Links

• 19729666

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 18, 2016
• First Posted (Estimate): October 19, 2016

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 18, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Pulmonary Disease, Chronic Obstructive; Xuebijing
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease
• Other Study ID Numbers: WK-2016-HR-02; Chinese PLA General Hospital (Other Identifier: Chinese PLA General Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED