Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD

Study Overview
=================
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).

Official Title
-----------------
Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD：a Multicentre Randomised Controlled Trial

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Xuebijing
* Drug: Placebo


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pulmonary Disease, Chronic Obstructive, Xuebijing