Who is sponsoring NCT05213507?

NCT05213507 is sponsored by Shanghai Zhongshan Hospital.

What condition does NCT05213507 study?

NCT05213507 studies COPD, COPD Exacerbation.

What drugs are being tested in NCT05213507?

Interventions: aerosol inhaled Amikacin Sulfate Injection, conventional therapy.

What is the status of NCT05213507?

NCT05213507 is currently UNKNOWN.

Last reviewed 2022-02-07 · How we verify

Inhaled Amikacin in Preventing Acute Exacerbation of Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD): a Multicenter Clinical Study

NCT05213507 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Shanghai Zhongshan Hospital
Phase	Phase 3
Status	UNKNOWN
Enrolment	136
Start date	2022-03
Completion	2023-12

Conditions

COPD
COPD Exacerbation

Interventions

aerosol inhaled Amikacin Sulfate Injection
conventional therapy

Primary outcomes

Time to the first COPD acute exacerbation — 15 months
COPD acute exacerbation refers to the deterioration of daily symptoms, which requires treatment with antibiotics or systemic glucocorticoid therapy. The first COPD acute exacerbations was defined as the date of occurrence of the first AECOPD starting from the day of the first dose to one day after the last visit.

Countries

China