AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs
Information source: Bayer
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bronchitis, Chronic
Intervention: Avelox (Moxifloxacin, BAY12-8039) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
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.
Clinical Details
Official title: AVANTI - Avelox® in Acute Exacerbations of Chronic Bronchitis
Study design: Cohort, Prospective
Primary outcome: Time until improvement of acute exacerbation
Secondary outcome: Time until cure of acute exacerbationSeverity of AECB according to Antonisen criteria Impact of AECB on daily life activities Safety of Avelox under daily life treatment conditions
Eligibility
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Exclusion Criteria:
- Exclusion criteria must be read in conjunction with the local product information.
Locations and Contacts
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com
Many Locations, Albania; Recruiting
Many Locations, Bosnia and Herzegovina; Recruiting
Many Locations, Kazakhstan; Recruiting
Many Locations, Macedonia, The Former Yugoslav Republic of; Recruiting
Many Locations, Moldova, Republic of; Recruiting
Many Locations, Russian Federation; Recruiting
Many Locations, Slovakia; Recruiting
Many Locations, Ukraine; Recruiting
Additional Information
Click here and search for drug information provided by the FDA Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product Click here to find results for studies related to marketed products
Starting date: June 2008
Ending date: November 2009
Last updated: October 19, 2009
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