Evaluate the Efficacy of Xuebijing Injection in Acute Exacerbations of COPD

NCT02937974 | Unknown Phase 4 DMC

• 2 other identifiers: WK-2016-HR-02Chinese PLA General Hospital
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; Xuebijing

Outcome Measures

Primary Outcomes (1)

• Invasive mechanical ventilation rate

  Invasive mechanical ventilation rate in %

  28 days

Secondary Outcomes (1)

• length of Hospital stay

  28 days

Study Arms (2)

Xuebijing

EXPERIMENTAL

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

Drug: Xuebijing

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Xuebijing DRUG

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

Xuebijing

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• First Hospitals affiliated to the China PLA General Hospital: collaborator
• Navy General Hospital, Beijing: collaborator
• Rocket Force General Hospital，Chinese People's Liberation Army: collaborator
• 307 Hospital of PLA: collaborator
• Beijing Shijitan Hospital, Capital Medical University: collaborator

Study Sites (1)

Chinese PLA General Hospital

Beijing, 100853, China

Location

Related Publications (2)

• 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.

  PMID: 19729666 BACKGROUND

• 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.

  PMID: 30777117 DERIVED

Related Links

• 19729666

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Xuebijing

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lixin Xie, Professor

  Chinese PLA General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 19, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

CN (1)