NCT00656747

Moxifloxacin Versus Amoxicillin Clavulanic Acid in Treatment of Acute Exacerbation of Chronic Bronchitis

MAESTRAL - A Prospective, Multinational, Multicenter, Randomized, Double Blind, Double Dummy, Controlled Study Comparing the Efficacy and Safety of Moxifloxacin to That of Amoxicillin Clavulanic Acid for the Treatment of Subjects With Acute Exacerbations of Chronic Bronchitis.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,372 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

A study to assess the safety and efficacy of moxifloxacin compared to that of amoxicillin-clavulanic acid for the treatment of subjects with acute exacerbation of chronic bronchitis.

Conditions

• Chronic Bronchitis

Interventions

Type	Name	Description
DRUG	Avelox (Moxifloxacin, BAY12-8039)	Subjects will be randomised to moxifloxacin 400 mg PO OD (5 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.
DRUG	Amoxicillin clavulanic acid	Subjects will be randomised to amoxicillin-clavulanic acid 875/125 mg PO BID (7 days). Subjects will also take placebo tablets, so that each subject takes 3 tablets per day for 7 days. Prior to randomization, subjects are stratified based on co-administration of short-course systemic steroids.

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2008-04-11
• Last updated: 2014-12-01

Locations

220 sites across 31 countries: Andorra, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Latvia, Lithuania, Mexico, Netherlands, Pakistan, Peru, Philippines, Portugal, South Africa, Spain, Switzerland, Thailand, United Kingdom