drugset / Trial / NCT03449459

Prevention of Acute Exacerbation in Subjects With COPD by Bacterial Decolonization in Lower Respiratory Tract

NCT03449459 ↗

RandomizedParallel-groupOpen-labelPrevention

Summary

The colonization of potential pathogenic bacteria in lower respiratory tract is thought to be accountable for acute exacerbation in subjects with moderate to severe COPD. However, there is no accepted therapy for patients with COPD to remove the colonized bacteria in lower respiratory tract. Therefore, we plan to perform a multi-center, randomized, controlled trial to study the efficacy and safety of oral probiotics, aerosol inhaled amikacin or combined vaccination to decolonize bacteria in lower respiratory tract and prevent acute exacerbation of COPD.

Timeline

Start
2018-12-01
Primary completion
2020-12-01
Completion
2020-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject 23-valent pneumococcal polysaccharide vaccine Vaccine — —
Subject Amikacin Small molecule 0.4 g Inhaled
Subject Influenza vaccine Vaccine — —