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| Sponsored by: |
Bayer |
|---|---|
| Information provided by: | Bayer |
| ClinicalTrials.gov Identifier: | NCT00876577 |
Purpose
This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from an acute exacerbation of chronic bronchitis and take at least one dose of Moxifloxacin injection.The primary objective is to obtain clinical effectiveness and safety data of Moxifloxacin injection in the treatment of acute exacerbations of chronic bronchitis in patients in whom Moxifloxacin was routinely prescribed. The secondary objective is to find out the possible correlation between the risk factors (sex, smoking, number of previous exacerbations, etc) and AECB, the different treatment effectiveness according to Anthonisen classification. This study will also collect the data of pathogens by sputum culture and the defervescence time of Moxifloxacin injection in treating Acute Exacerbations of Chronic Bronchitis (AECB).
| Condition | Intervention |
|---|---|
|
Chronic Bronchitis |
Drug: Moxifloxacin (Avelox, BAY12-8039) |
| Study Type: | Observational |
| Study Design: | Cohort, Prospective |
| Official Title: | VICTOR - Avelox® i.v. in Acute Exacerbations of Chronic Bronchitis |
| Estimated Enrollment: | 1200 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Group 1 |
Drug: Moxifloxacin (Avelox, BAY12-8039)
Patients from the normal praxis routine, treated with Moxifloxacin injection with/without sequential tablet treatment according to the local product information
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Adult female and male patients with AECB, who are at least 18 years of age and are scheduled to be treated with Moxifloxacin injection, independent of the duration and severity of the underlying chronic bronchitis, can be documented after the therapy decision has been made.
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bayer Clinical Trials Contact | clinical-trials-contact@bayerhealthcare.com |
| China | |
| Many Locations, China | |
| Study Director: | Bayer Study Director | Bayer |
More Information
| Responsible Party: | Bayer Healthcare AG ( Medical Director ) |
| Study ID Numbers: | 14495, AX0810CN |
| Study First Received: | April 3, 2009 |
| Last Updated: | April 3, 2009 |
| ClinicalTrials.gov Identifier: | NCT00876577 History of Changes |
| Health Authority: | China: Federal Institute for Drugs and Medical Devices |
|
Acute Exacerbations of Chronic Bronchitis Avelox Bronchitis Disease Exacerbation |
|
Acute Disease Bronchitis, Chronic Lung Diseases, Obstructive Respiratory Tract Infections Respiratory Tract Diseases |
Bronchial Diseases Moxifloxacin Lung Diseases Bronchitis Pulmonary Disease, Chronic Obstructive |
|
Acute Disease Anti-Infective Agents Disease Attributes Bronchial Diseases Pharmacologic Actions Bronchitis, Chronic Lung Diseases, Obstructive Pathologic Processes |
Respiratory Tract Diseases Respiratory Tract Infections Moxifloxacin Therapeutic Uses Lung Diseases Bronchitis Pulmonary Disease, Chronic Obstructive |
