Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02937974
• Other study ID #: WK-2016-HR-02
• Secondary ID: Chinese PLA Gene
• Status: Active, not recruiting
• Phase: Phase 4
• First received: October 13, 2016
• Last updated: October 18, 2016
• Start date: October 2016
• Est. completion date: December 2018

Study information

• Verified date: October 2016
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 254
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing

Sponsors (6)

Lead Sponsor	Collaborator
Chinese PLA General Hospital	Beijing Shijitan Hospital, First Hospitals affiliated to the China PLA General Hospital, Navy General Hospital,Chinese People's Liberation Army, Rocket Force General Hospital,Chinese People's Liberation Army, The 307th Hospital of Chinese People's Liberation Army

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive mechanical ventilation rate	Invasive mechanical ventilation rate in %	28 days	Yes
Secondary	length of Hospital stay	Invasive mechanical ventilation rate in days	28 days

External Links

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