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Inhaled Amikacin in Preventing AECOPD

NCT05213507 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2022-02-23

No results posted yet for this study

Summary

The underlying bacterial colonization in lower respiratory tract (LRT) of COPD patients may be related to acute exacerbation of COPD (AECOPD) and disease progression. However, there is a lack of strong evidence on the effect of LRT bacterial decolonization on COPD. This study was designed to confirm the prophylactic effect of decolonization of LRT bacteria on AECOPD and establish a novel prophylactic therapy for sable COPD.

Conditions

  • COPD
  • COPD Exacerbation

Interventions

DRUG

aerosol inhaled Amikacin Sulfate Injection

0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 7-10 days per month, for 3 months.

OTHER

conventional therapy

According to the personal characteristics of subjects and guidance of The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2021, the doctor in charge prescribes appropriate medication, including but not limited to bronchodilators, inhaled corticosteroids and long-term oxygen therapy.

Sponsors & Collaborators

  • Shanghai Zhongshan Hospital

    lead OTHER

Principal Investigators

  • Jing Zhang, MD, PhD · Zhongshan hospital, Shanghai Medical College, Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-31
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05213507 on ClinicalTrials.gov