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 (XYP-202401)

December 23, 2024 updated by: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1140

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Xiyuan Hospital of China Academy of Chinese Medical Sciences
  • Phone Number: 010-62835646

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with acute exacerbation of chronic obstructive pulmonary disease

Description

Inclusion Criteria:

  1. Discharged with chronic obstructive pulmonary disease;
  2. Hospitalized patients with COPD or AECOPD combined with lower respiratory tract infection;
  3. The treatment course of Xiyanping injection in the exposed group was ≥3 days, and the non-exposed group did not use Xiyanping injection;
  4. Study patients with complete medical records.

Exclusion Criteria:

  1. 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;
  2. Patients with viral pneumonia or other systemic infection (such as urinary tract infection);
  3. Patients who do not use intravenous antibiotics;
  4. Refuse the case to be used by researchers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exposure group
Xiyanping injection + Antimicrobial agents treatment
Drug: Xiyanping injection+ antibiotic
Xiyanping injection+ antibiotic
Non-exposure group
Antimicrobial agents treatment
Drug: Antibiotic
Antibiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Course of intravenous antibiotics
Time Frame: baseline, at 3(±1), 7(±1), and 10 days during medication
Duration of intravenous antibiotic use
baseline, at 3(±1), 7(±1), and 10 days during medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

December 15, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 23, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024XLA207-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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