Clinical trial NCT02937857: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bronchitis
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2016-10-19
Enrollment: 240
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: time to total score of the clinical symptoms/signs decreased more than 70% from baseline
timeFrame: up to 30 days after the last Administration
Secondary outcomes:
measure: The total efficiency rate
timeFrame: Day 3 and Day 5
measure: Time to defervescence
timeFrame: up to 30 days after the last Administration
measure: Day(s) of Hospital Stay
timeFrame: up to 30 days after the last Administration
measure: Signs and Symptoms Score from baseline
timeFrame: up to 30 days after the last Administration
measure: Antibiotic consumption
timeFrame: up to 30 days after the last Administration
measure: Usage of Inhaled corticosteroids
timeFrame: up to 30 days after the last Administration
measure: Incidence of complication
timeFrame: up to 30 days after the last Administration
measure: Sputum status
timeFrame: up to 30 days after the last Administration
measure: Expenditure of therapeutic drug
timeFrame: up to 30 days after the last Administration
measure: The total expenditure of treatment
timeFrame: up to 30 days after the last Administration
measure: incidence of adverse events
timeFrame: up to 30 days after the last Administration
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou women and children health care center
state: Guangdong
Study officials:
affiliation: Sichuan University
name: Liu Han Min, professor
role: PRINCIPAL_INVESTIGATOR
References: