drugset / Trial / NCT03449459
Prevention of Acute Exacerbation in Subjects With COPD by Bacterial Decolonization in Lower Respiratory Tract
Phase 0
Completed
144 enrolled
Shanghai Zhongshan Hospital
Ruijin Hospital · collabThe First Affiliated Hospital of Guangzhou Medical University · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Amikacin | Small molecule | 0.4 g | Inhaled |
| Subject | Influenza Virus Vaccine | Vaccine | — | — |
| Subject | Pneumovax 23 | Vaccine | — | — |