AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs
9 other identifiers
observational
2,672
8 countries
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2008
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 18, 2009
CompletedFirst Posted
Study publicly available on registry
February 19, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedJuly 9, 2012
July 1, 2012
2 years
February 18, 2009
July 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time until improvement of acute exacerbation
End of study
Secondary Outcomes (4)
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
Study Arms (1)
Group 1
Interventions
Patients with acute exacerbation of chronic bronchitis for whom the physician decided to prescribe moxifloxacin
Eligibility Criteria
Primary care clinic
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (8)
Unknown Facility
Many Locations, Albania
Unknown Facility
Many Locations, Bosnia and Herzegovina
Unknown Facility
Many Locations, Kazakhstan
Unknown Facility
Many Locations, Moldova
Unknown Facility
Many Locations, North Macedonia
Unknown Facility
Many Locations, Russia
Unknown Facility
Many Locations, Slovakia
Unknown Facility
Many Locations, Ukraine
Related Publications (1)
Chuchalin A, Zakharova M, Dokic D, Tokic M, Marschall HP, Petri T. Efficacy and safety of moxifloxacin in acute exacerbations of chronic bronchitis: a prospective, multicenter, observational study (AVANTI). BMC Pulm Med. 2013 Jan 23;13:5. doi: 10.1186/1471-2466-13-5.
PMID: 23343427DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 18, 2009
First Posted
February 19, 2009
Study Start
April 1, 2008
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
July 9, 2012
Record last verified: 2012-07