drugset / Trial / NCT01710488

Comparison Between Levofloxacin and Prulifloxacin, in Internal Medicine Patients With Acute Exacerbation of COPD

NCT01710488

Phase 4 Completed 258 enrolled Fadoi Foundation, Italy
RandomizedParallel-groupSingle-blindTreatment

Summary

The primary objective of the study is to determine the percentage of patients with "therapeutic success" at the end of the cycle of antibiotic therapy (10 days), in the two treatment groups (levofloxacin and prulifloxacin). The effect of study treatments will be evaluated on the basis of a score determined in relation to the signs-symptoms of acute exacerbation of COPD (sputum purulence, sputum volume, cough, dyspnea, fever)

Timeline

Start
2009-05
Primary completion
2013-11
Completion
2013-11

Drugs

EvaluationDrugModalityDoseRoute
Comparator Levofloxacin Small molecule 500 mg
Subject Prulifloxacin Small molecule 600 mg