AVANTI - Avelox® in Acute Exacerbations of chronic bronchitis


Tracking Information

Start Date  ICMJEJune 2008
Primary Completion DateSeptember 2009   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: February 18, 2009)		Time until improvement of acute exacerbation [ Time Frame: End of study ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00846911 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: February 18, 2009)
  • Time until cure of acute exacerbation [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Severity of AECB according to Antonisen criteria [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Impact of AECB on daily life activities [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Safety of Avelox under daily life treatment conditions [ Time Frame: Throughout treatment ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEAVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs
Official Title  ICMJEAVANTI - Avelox® in Acute Exacerbations of Chronic Bronchitis
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 
Study PhasePhase IV
Study Type  ICMJEObservational
Study Design  ICMJECohort, Prospective
Condition  ICMJEBronchitis, Chronic
Intervention  ICMJEDrug: Avelox (Moxifloxacin, BAY12-8039)
Patients with acute exacerbation of chronic bronchitis for whom the physician decided to prescribe moxifloxacin
Study Arms / Comparison GroupsGroup 1
Intervention: Drug: Avelox (Moxifloxacin, BAY12-8039)

Recruitment Information

Estimated Enrollment  ICMJE1600
Estimated Completion DateNovember 2009
Primary Completion DateSeptember 2009   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
GenderBoth
Ages35 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Bayer Clinical Trials Contactclinical-trials-contact@bayerhealthcare.com
Location Countries  ICMJEAlbania,   Bosnia and Herzegovina,   Kazakhstan,   Macedonia, The Former Yugoslav Republic of,   Moldova, Republic of,   Russian Federation,   Slovakia,   Ukraine

Administrative Information

NCT ID  ICMJENCT00846911
Responsible PartyGlobal Medical Affairs Head, Bayer Schering Pharma AG
Study ID Numbers  ICMJE14689, AX0701, 13598, 13855, 13856, 13857, 14008, 14007, 14009
Study Sponsor  ICMJEBayer
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bayer Study DirectorBayer
Information Provided ByBayer