Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

254 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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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

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Xuebijing

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

Group Type EXPERIMENTAL

Xuebijing

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Xuebijing

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

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No