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

Primary Purpose

Bronchitis

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Standard treatment only
Standard treatment+Xiyanping injection
Sponsored by
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchitis

Eligibility Criteria

1 Year - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangzhou women and children health care centerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard treatment only

Standard treatment+Xiyanping injection

Arm Description

Standard treatment only such as antiasthmatic, expectorant and antipyretic

Standard Treatment such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection intravenous administration of 0.2-0.4mL/kg/day ,QD for 5 days.

Outcomes

Primary Outcome Measures

time to total score of the clinical symptoms/signs decreased more than 70% from baseline

Secondary Outcome Measures

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

Full Information

First Posted
September 20, 2016
Last Updated
December 4, 2017
Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02937857
Brief Title
An Add-on Study to Evaluate the Efficacy and Safety of Xiyanping Injection in Pediatric Bronchitis Patients.
Official Title
A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Subjects With Pediatric Bronchitis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangxi Qingfeng Pharmaceutical Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard treatment only
Arm Type
Active Comparator
Arm Description
Standard treatment only such as antiasthmatic, expectorant and antipyretic
Arm Title
Standard treatment+Xiyanping injection
Arm Type
Experimental
Arm Description
Standard Treatment such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection intravenous administration of 0.2-0.4mL/kg/day ,QD for 5 days.
Intervention Type
Drug
Intervention Name(s)
Standard treatment only
Other Intervention Name(s)
antiasthmatic,expectorant,antipyretic
Intervention Description
standard treatment， such as antiasthmatic,expectorant,antipyretic
Intervention Type
Drug
Intervention Name(s)
Standard treatment+Xiyanping injection
Other Intervention Name(s)
antiasthmatic,expectorant,antipyretic + Xiyanping injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
The total efficiency rate
Time Frame
Day 3 and Day 5
Title
Time to defervescence
Time Frame
up to 30 days after the last Administration
Title
Day(s) of Hospital Stay
Time Frame
up to 30 days after the last Administration
Title
Signs and Symptoms Score from baseline
Time Frame
up to 30 days after the last Administration
Title
Antibiotic consumption
Description
check and record the usage of antibiotic,including durg Utilization Rate and the duration of usage
Time Frame
up to 30 days after the last Administration
Title
Usage of Inhaled corticosteroids
Description
check and record the usage of Inhaled corticosteroids,including durg Utilization Rate and the duration of usage
Time Frame
up to 30 days after the last Administration
Title
Incidence of complication
Description
record the incidence of new complication after treatment.
Time Frame
up to 30 days after the last Administration
Title
Sputum status
Description
record the incidence of expectoration and the day of expectoration disappear
Time Frame
up to 30 days after the last Administration
Title
Expenditure of therapeutic drug
Time Frame
up to 30 days after the last Administration
Title
The total expenditure of treatment
Description
Expenditure of treatment include the cost of durg, hospitalization,examination
Time Frame
up to 30 days after the last Administration
Title
incidence of adverse events
Time Frame
up to 30 days after the last Administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Xiao
Phone
010-84682600
Email
chenxiao@sh-qingfeng.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liu Han Min, professor
Organizational Affiliation
Sichuan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou women and children health care center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510623
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deng Li, professor
Phone
020-38076348
Email
drdengli@126.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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