Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseXYP-202401NCT06754865
Study to Evaluate the Clinical Value and Safety of Xiyanping Injection in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD) Based on Real-world Clinical Data
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd..
Trial summary
The primary objective is to evaluate the effect of Xiyanping injection on the treatment course of intravenous antibiotics for acute exacerbation of chronic obstructive pulmonary disease based on real-world clinical data, and to provide guidance and basis for the clinical application of Xiyanping injection combined… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- What is being tested?
- Xiyanping injection+ antibiotic and Antibiotic
- Type of treatment
- Injection or infusion
- How many people
- 1,140 participants
- Where
- No sites listed yet
- Study dates
- Dec 2024to Nov 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with acute exacerbation of chronic obstructive pulmonary disease
Who may be able to join
- Discharged with chronic obstructive pulmonary disease;
- Hospitalized patients with COPD or AECOPD combined with lower respiratory tract infection;
- The treatment course of Xiyanping injection in the exposed group was ≥3 days, and the non-exposed group did not use Xiyanping injection;
- Study patients with complete medical records.
Who cannot join
- Researchers believe that multiple proprietary Chinese medicines with the same or similar functions (such as Tanreqing injection, Reduning injection, Yanhuning injection, etc.) have been used at the same time during treatment, resulting in no assessment of efficacy or safety;
- Patients with viral pneumonia or other systemic infection (such as urinary tract infection);
- Patients who do not use intravenous antibiotics;
- Refuse the case to be used by researchers.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Xiyuan Hospital of China Academy of Chinese Medical Sciences contact
About this study
Official title: A Muulticenter, Open, Non-interventional, Retrospective Cohort Study to Evaluate the Clinical Value and Safety of Xiyanping Injection in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD) Based on Real-world Clinical Data
The primary objective is to evaluate the effect of Xiyanping injection on the treatment course of intravenous antibiotics for acute exacerbation of chronic obstructive pulmonary disease based on real-world clinical data, and to provide guidance and basis for the clinical application of Xiyanping injection combined with antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease.The secondary objectives is to evaluate the effect of Xiyanping injection on the indicators of acute exacerbation of inflammation and symptom improvement of chronic obstructive pulmonary disease.
- Being tested
- Xiyanping injection+ antibiotic, Antibiotic
- Keywords
- Acute exacerbation of chronic obstructive pulmonary disease, Xiyanping injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xiyanping injection+ antibioticDrug
Xiyanping injection+ antibiotic
AntibioticDrug
Antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Exposure group | Xiyanping injection + Antimicrobial agents treatment Receives: Drug: Xiyanping injection+ antibiotic | |
| Non-exposure group | Antimicrobial agents treatment Receives: Drug: Antibiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of intravenous antibiotics
Duration of intravenous antibiotic use
Measured: baseline, at 3(±1), 7(±1), and 10 days during medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study startDec 2024 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Exacerbation of Chronic Obstructive Pulmonary DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06754865
- Sponsor's protocol ID
- 2024XLA207-1
- Acronym
- XYP-202401
- Status last verified
- Dec 2024
- First submitted
- 15 Dec 2024
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Muulticenter, Open, Non-interventional, Retrospective Cohort Study to Evaluate the Clinical Value and Safety of Xiyanping Injection in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease(COPD) Based on Real-world Clinical Data
- ClinicalTrials.gov ID
- NCT06754865
- Acronym / sponsor ID
- XYP-202401 / 2024XLA207-1
- Keywords
- Acute exacerbation of chronic obstructive pulmonary disease, Xiyanping injection
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,140 participants (estimated)
- Lead sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2024 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 1 Jan 2025 (actual)
- 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.
The primary objective is to evaluate the effect of Xiyanping injection on the treatment course of intravenous antibiotics for acute exacerbation of chronic obstructive pulmonary disease based on real-world clinical data, and to provide guidance and basis for the clinical application of Xiyanping injection combined with antibiotics in the treatment of acute exacerbation of chronic obstructive pulmonary disease.The secondary objectives is to evaluate the effect of Xiyanping injection on the indicators of acute exacerbation of inflammation and symptom improvement of chronic obstructive pulmonary disease.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposure group | – | Drug: Xiyanping injection+ antibioticXiyanping injection + Antimicrobial agents treatment |
| Non-exposure group | – | Drug: AntibioticAntimicrobial agents treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with acute exacerbation of chronic obstructive pulmonary disease
Key inclusion criteria (4 listed)
- Discharged with chronic obstructive pulmonary disease;
- Hospitalized patients with COPD or AECOPD combined with lower respiratory tract infection;
- The treatment course of Xiyanping injection in the exposed group was ≥3 days, and the non-exposed group did not use Xiyanping injection;
- Study patients with complete medical records.
Key exclusion criteria (4 listed)
- Researchers believe that multiple proprietary Chinese medicines with the same or similar functions (such as Tanreqing injection, Reduning injection, Yanhuning injection, etc.) have been used at the same time during treatment, resulting in no assessment of efficacy or safety;
- Patients with viral pneumonia or other systemic infection (such as urinary tract infection);
- Patients who do not use intravenous antibiotics;
- Refuse the case to be used by researchers.
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 |
|---|---|---|
| Xiyanping injection+ antibioticXiyanping injection+ antibiotic | Drug | Exposure group |
| AntibioticAntibiotic | Drug | Non-exposure group |
Primary outcome
Course of intravenous antibiotics
Time frame: baseline, at 3(±1), 7(±1), and 10 days during medication
Duration of intravenous antibiotic use
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
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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.
Xiyuan Hospital of China Academy of Chinese Medical Sciences contact
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Exacerbation of Chronic Obstructive Pulmonary Disease, run by Jiangxi Qingfeng Pharmaceutical Co. Ltd..
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 1 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiyuan Hospital of China Academy of Chinese Medical Sciences (010-62835646), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Course of intravenous antibiotics (time frame: baseline, at 3(±1), 7(±1), and 10 days during medication). 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 1 Jan 2025.