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

Phase 4

• Conditions: Bronchitis
• Interventions: Drug: Standard treatment+Xiyanping injection; Drug: Standard treatment only

• Registration Number: NCT02937857
• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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

Study Timeline

• Study Start: 2016-08
• Status Verified: 2016-09
• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-10-17
• Study First Posted: 2016-10-19
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06
• Primary Completion: 2020-04
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard treatment+Xiyanping injection	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.
Standard treatment only	Standard treatment only	Standard treatment only such as antiasthmatic, expectorant and antipyretic

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Guangzhou women and children health care center; 🇨🇳 Guangzhou, Guangdong, China