BronchitisPhase 4NCT02937857
An Add-on Study to Evaluate the Efficacy and Safety of Xiyanping Injection in Pediatric Bronchitis Patients.
A Phase 4 study testing Standard treatment only and Standard treatment+Xiyanping injection in people with Bronchitis, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, open Label,add-on study. Read more about this study
- Who is it for?
- Ages 1 year to 3 years
- Conditions the study is for
- Bronchitis
- What is being tested?
- Standard treatment only and Standard treatment+Xiyanping injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Aug 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guangzhou women and children health care center
Guangzhou, Guangdong, 510623
Deng Li, professor, 020-38076348, drdengli@126.com
About this study
Official title: A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Subjects With Pediatric Bronchitis
This is a multicenter, randomized, open Label,add-on study.
Read the 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
- Conditions
- Bronchitis
- Being tested
- Standard treatment only, Standard treatment+Xiyanping injection
- Medical subject headings
- Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard treatment onlyDrug
Also called antiasthmatic,expectorant,antipyretic
standard treatment， such as antiasthmatic,expectorant,antipyretic
Standard treatment+Xiyanping injectionDrug
Also called antiasthmatic,expectorant,antipyretic + 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.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment only | Active comparator | Standard treatment only such as antiasthmatic, expectorant and antipyretic Receives: Drug: Standard treatment only |
| Standard treatment+Xiyanping injection | Experimental | Standard Treatment such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection intravenous administration of 0.2-0.4mL/kg/day ,QD for 5 days. Receives: Drug: Standard treatment+Xiyanping injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to total score of the clinical symptoms/signs decreased more than 70% from baseline
Measured: up to 30 days after the last Administration
Secondary outcomes (11)
The total efficiency rate
Measured: Day 3 and Day 5
Time to defervescence
Measured: up to 30 days after the last Administration
Day(s) of Hospital Stay
Measured: up to 30 days after the last Administration
Signs and Symptoms Score from baseline
Measured: up to 30 days after the last Administration
Antibiotic consumption
check and record the usage of antibiotic,including durg Utilization Rate and the duration of usage
Measured: up to 30 days after the last Administration
Usage of Inhaled corticosteroids
check and record the usage of Inhaled corticosteroids,including durg Utilization Rate and the duration of usage
Measured: up to 30 days after the last Administration
Incidence of complication
record the incidence of new complication after treatment.
Measured: up to 30 days after the last Administration
Sputum status
record the incidence of expectoration and the day of expectoration disappear
Measured: up to 30 days after the last Administration
Expenditure of therapeutic drug
Measured: up to 30 days after the last Administration
The total expenditure of treatment
Expenditure of treatment include the cost of durg, hospitalization,examination
Measured: up to 30 days after the last Administration
incidence of adverse events
Measured: up to 30 days after the last Administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startAug 2016
- Primary completionApr 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Liu Han Min, professor, Principal investigator, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02937857
- Sponsor's protocol ID
- JXQF-XYP-1606
- Status last verified
- Sep 2016
- First submitted
- 20 Sep 2016
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Subjects With Pediatric Bronchitis
- ClinicalTrials.gov ID
- NCT02937857
- Acronym / sponsor ID
- JXQF-XYP-1606
- Conditions
- Bronchitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard treatment only | Active comparator | Drug: Standard treatment onlyStandard treatment only such as antiasthmatic, expectorant and antipyretic |
| Standard treatment+Xiyanping injection | Experimental | Drug: Standard treatment+Xiyanping injectionStandard Treatment such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection intravenous administration of 0.2-0.4mL/kg/day ,QD for 5 days. |
Who may qualify
- Ages
- 1 year to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (15 listed)
- Participants with severe clinical symptoms, meet any of the following：
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard treatment onlyAlso: antiasthmatic,expectorant,antipyreticstandard treatment， such as antiasthmatic,expectorant,antipyretic | Drug | Standard treatment only |
| Standard treatment+Xiyanping injectionAlso: antiasthmatic,expectorant,antipyretic + Xiyanping injectionstandard treatment+Xiyanping injection:standard treatment， such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection,0.2-0.4mL/kg/day,qd for 5 days. | Drug | Standard treatment+Xiyanping injection |
Primary outcome
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
11 secondary outcomes
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
Usage of Inhaled corticosteroids
Time frame: up to 30 days after the last Administration
Incidence of complication
Time frame: up to 30 days after the last Administration
Sputum status
Time frame: up to 30 days after the last Administration
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
incidence of adverse events
Time frame: up to 30 days after the last Administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liu Han Min, professor principal investigator
Sichuan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard treatment only and Standard treatment+Xiyanping injection in people with Bronchitis, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Xiao (010-84682600, chenxiao@sh-qingfeng.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.