SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe Acute Exacerbations of Chronic Bronchitis (AECB)

Completed

• Conditions: Chronic Bronchitis
• Interventions: Drug: Moxifloxacin (Avelox, BAY12-8039)

• Registration Number: NCT00879008
• Lead Sponsor: Bayer

Brief Summary

In this study data of patients with moderate or severe acute exacerbations of chronic bronchitis (AECB) were collected. There were two different cohorts which were compared (Moxifloxacin and other antibiotics) concerning effectiveness and tolerance. It was a prospective study which was accomplished in 100 ambulatory practice offices.

Detailed Description

The study design was slightly changed to adapt the target population. Due to these changes the study was restarted on 8th December 2009.

Study Timeline

• Study First Submitted: 2009-04-08
• Study First Submitted QC: 2009-04-08
• Study First Posted: 2009-04-09
• Study Start: 2009-12
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-20
• Last Update Posted: 2014-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

• Acute exacerbation of chronic bronchitis from Anthonisen type I or II
• FEV1 of < 50 %
• Patient must be ensured in the statutory health insurance
• Further contraindications of the prescribed pharmaceutical products must be considered

Exclusion Criteria

• Patients who change from one cohort to the other

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Moxifloxacin (Avelox, BAY12-8039)	-

Primary Outcome Measures

Name	Time	Method
Effectiveness and tolerance of/to the different therapies	within the first 14 days
Possible hospitalisation rate	within the first 14 days