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

NCT06754865 | Not Yet Recruiting

• 1 other identifier: 2024XLA207-1
• Study Type: observational
• Target: 1,140
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Acute Exacerbation of Chronic Obstructive Pulmonary Disease

Keywords

Acute exacerbation of chronic obstructive pulmonary disease; Xiyanping injection

Outcome Measures

Primary Outcomes (1)

• Course of intravenous antibiotics

  Duration of intravenous antibiotic use

  baseline, at 3(±1), 7(±1), and 10 days during medication

Study Arms (2)

Exposure group

Xiyanping injection + Antimicrobial agents treatment

Drug: Xiyanping injection+ antibiotic

Non-exposure group

Antimicrobial agents treatment

Drug: Antibiotic

Interventions

Xiyanping injection+ antibiotic DRUG

Xiyanping injection+ antibiotic

Exposure group

Antibiotic DRUG

Antibiotic

Non-exposure group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with acute exacerbation of chronic obstructive pulmonary disease

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangxi Qingfeng Pharmaceutical Co. Ltd.: lead

MeSH Terms

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Xiyuan Hospital of China Academy of Chinese Medical Sciences

CONTACT

010-62835646

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2024
• First Posted: January 1, 2025
• Study Start: December 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 1, 2025

Record last verified: 2024-12