An Add-on Study to Evaluate the Efficacy and Safety of Xiyanping Injection in Pediatric Bronchitis Patients.

Overview

This is a multicenter, randomized, open Label,add-on study.

Full Title of Study: “A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Subjects With Pediatric Bronchitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2020

Detailed Description

This is an add-on study of efficacy and safety of intravenous injection of Xiyanping injection in subjects with pediatric bronchitis.

The purpose to determine the efficacy and safety of conventional treatment combined with or without Xiyanping injection in the treatment of pediatric bronchitis and to further evaluate the clinical value of Xiyanping injection in shortening the course of pediatric bronchitis

The study will enroll 240 Pediatric bronchitis volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive Routine treatment for pediatric bronchitis and Xiyanping injection; volunteers from the second group will receive Routine treatment for pediatric bronchitis. Xiyanping injection will be administration as intravenous injection of 0.2-0.4mL/kg/day once daily for 5 days concomitantly with Routine treatment for pediatric bronchitis

Interventions

  • Drug: Standard treatment only
    • standard treatment, such as antiasthmatic,expectorant,antipyretic
  • Drug: Standard treatment+Xiyanping injection
    • standard treatment+Xiyanping injection:standard treatment, such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection,0.2-0.4mL/kg/day,qd for 5 days.

Arms, Groups and Cohorts

  • Active Comparator: Standard treatment only
    • Standard treatment only such as antiasthmatic, expectorant and antipyretic
  • Experimental: Standard treatment+Xiyanping injection
    • Standard Treatment such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection intravenous administration of 0.2-0.4mL/kg/day ,QD for 5 days.

Clinical Trial Outcome Measures

Primary Measures

  • time to total score of the clinical symptoms/signs decreased more than 70% from baseline
    • Time Frame: up to 30 days after the last Administration

Secondary Measures

  • The total efficiency rate
    • Time Frame: Day 3 and Day 5
  • Time to defervescence
    • Time Frame: up to 30 days after the last Administration
  • Day(s) of Hospital Stay
    • Time Frame: up to 30 days after the last Administration
  • Signs and Symptoms Score from baseline
    • Time Frame: up to 30 days after the last Administration
  • Antibiotic consumption
    • Time Frame: up to 30 days after the last Administration
    • check and record the usage of antibiotic,including durg Utilization Rate and the duration of usage
  • Usage of Inhaled corticosteroids
    • Time Frame: up to 30 days after the last Administration
    • check and record the usage of Inhaled corticosteroids,including durg Utilization Rate and the duration of usage
  • Incidence of complication
    • Time Frame: up to 30 days after the last Administration
    • record the incidence of new complication after treatment.
  • Sputum status
    • Time Frame: up to 30 days after the last Administration
    • record the incidence of expectoration and the day of expectoration disappear
  • Expenditure of therapeutic drug
    • Time Frame: up to 30 days after the last Administration
  • The total expenditure of treatment
    • Time Frame: up to 30 days after the last Administration
    • Expenditure of treatment include the cost of durg, hospitalization,examination
  • incidence of adverse events
    • Time Frame: up to 30 days after the last Administration

Participating in This Clinical Trial

Inclusion Criteria

  • Clinical diagnosis of pediatric bronchitis with hospital treatment needed
  • Males and female subjects
  • Age between 1 and 3 years old
  • With fever, cough, gasp and expectoration symptoms
  • Have wheeze and/ or mid-fine rales on one's lungs
  • White blood cell count < 12 x 109 / L, categorized priority to leukocyte
  • C-reactive protein≤8mg/L or normal Super C- reactive protein
  • Had experienced ≤48 h course before enrollment
  • Previous Wheezing episodes≤2
  • Written informed consent

Exclusion Criteria

  • Participants with severe clinical symptoms, meet any of the following:
  • SaO2≤0.92;(2)Shock or disturbance of consciousness;(3) Significantly speed up breathing , rapid pulse accompany with severe respiratory distress; or(4)Repeated occurrence of apnea or slow and irregular respiration;
  • Acute infectious disease such as measles, pertussis and influenza
  • Participants with bronchial asthma, bronchopneumonia and other respiratory diseases
  • Chronic lung diseases
  • Participants with complicated pyopneumothorax, airway obstruction, toxic encephalopathy, cardiac failure or respiratory failure
  • Participants with complicated severe underlying myocardial, liver, kidney, digestive and hematopoietic system diseases
  • Severe malnutrition and history of immune deficiency which may seriously affect the self-limiting process of the course
  • Participants with epilepsy and other disturbances of central nervous system
  • Participants with congenital diseases and psychosis
  • use of any other antiviral drugs within the 2 weeks before enrollment
  • use of systemic hormone within the 2 weeks before enrollment
  • Participants had a history of allergic constitution and drug allergy; Allergenic to XiYanPing injection and Andrographolide
  • Participants participated in other clinical research in the last three months
  • Any condition which would make the subject, in the opinion of the investigator or designee, not suitable for the study for any reason

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: 3 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jiangxi Qingfeng Pharmaceutical Co. Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Liu Han Min, professor, Principal Investigator, Sichuan University
  • Overall Contact(s)
    • Chen Xiao, 010-84682600, chenxiao@sh-qingfeng.net

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