Greatest International Antiinfective Trial With Avelox

Completed

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

• Registration Number: NCT00932802
• Lead Sponsor: Bayer

Brief Summary

The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2007-11
• Study Completion: 2007-11
• Study First Submitted: 2009-07-02
• Study First Submitted QC: 2009-07-02
• Study First Posted: 2009-07-03
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-16
• Last Update Posted: 2012-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50000

Inclusion Criteria

• Outpatients with diagnosis of AECB and decision taken by the investigator to prescribe moxifloxacin

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Exclusion Criteria

• Exclusion criteria must be read in conjunction with the local product information

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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
Evaluation of impact of AECB on the patient and the community as well as effect and safety of a treatment with moxifloxacin tablets in daily life clinical practice	During documentation at baseline and at at least one short-term follow-up visit; at maximum two short-term (within ca. 14 days) and two long-term follow-up visits (after ca. 6 and 12 months).

Secondary Outcome Measures

Name	Time	Method
Course of symptom relief	During documentation of up to two short-term follow-up visits (within ca. 14 days)
Speed of return to normal daily life activities	During documentation of the last short-term follow-up visit (after ca. 14 days)
Adverse events collection	Throughout the entire study, whenever Adverse Events occur
Evaluation of frequency of new exacerbations	During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
Progression of chronic respiratory disease	During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)