AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs
- Registration Number
- NCT00846911
- Lead Sponsor
- Bayer
- Brief Summary
The objective of this global non-interventional study is to evaluate the impact of Acute Exacerbation of Chronic Bronchitis(AECB) on the patient and the community as well as the safety and effect of a treatment with Moxifloxacin tablets in daily life clinical practice. This includes data on the course of symptom relief, speed of return to normal daily life activities as well as records on adverse events.
This study will be performed in accordance with international guidelines like EMEA (EMEA, EUDRALEX Volume 9A, Pharmacovigilance for Medicinal Products for Human Use) as well as local laws.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2672
Inclusion Criteria
- Patients at least 35 years of age with a diagnosis of Acute Exacerbation of Chronic Bronchitis (AECB) and decision taken by the investigator to treat with Avelox.
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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 Time until improvement of acute exacerbation End of study
- Secondary Outcome Measures
Name Time Method Time until cure of acute exacerbation End of study Severity of AECB according to Antonisen criteria Baseline Impact of AECB on daily life activities Baseline Safety of Avelox under daily life treatment conditions Throughout treatment