drugset / Trial / NCT05400369
A Study to Evaluate the Efficacy and Safety of Sitafloxacin in Adult Subjects With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Moxifloxacin | Small molecule | 400 mg | Oral |
| Subject | SITAFLOXACIN ANHYDROUS | Small molecule | 100 mg | Oral |