drugset / Trial / NCT05400369

A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease

NCT05400369

Phase 4 Completed 140 enrolled Daiichi Sankyo
RandomizedParallel-groupOpen-labelTreatment

Summary

Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease, that causes obstructed airflow from the lungs that causes persistent obstructive airflow limitation. Acute exacerbation, especially frequent exacerbation, is associated with an increased risk of death in COPD patients. The most common causes of acute attacks are viral and bacterial infections. This study will assess the efficacy and safety of sitafloxacin, a quinolone antibacterial drug, in participants with AECOPD.

Timeline

Start
2022-08-10
Primary completion
2024-09-25
Completion
2024-09-25

Drugs

EvaluationDrugModalityDoseRoute
Comparator Moxifloxacin Small molecule 400 mg Oral
Subject SITAFLOXACIN ANHYDROUS Small molecule 100 mg Oral