AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs

AVANTI - Avelox® in Acute Exacerbations of Chronic Bronchitis

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.

Study Overview

• Status: Completed
• Conditions: Bronchitis, Chronic
• Intervention / Treatment: Drug: Moxifloxacin (Avelox, BAY12-8039)

• Study Type: Observational
• Enrollment (Actual): 2672

Contacts and Locations

Study Locations

• Albania
  • Many Locations, Albania
• Bosnia and Herzegovina
  • Many Locations, Bosnia and Herzegovina
• Kazakhstan
  • Many Locations, Kazakhstan
• Macedonia, The Former Yugoslav Republic of
  • Many Locations, Macedonia, The Former Yugoslav Republic of
• Moldova, Republic of
  • Many Locations, Moldova, Republic of
• Russian Federation
  • Many Locations, Russian Federation
• Slovakia
  • Many Locations, Slovakia
• Ukraine
  • Many Locations, Ukraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1	Drug: Moxifloxacin (Avelox, BAY12-8039); Patients with acute exacerbation of chronic bronchitis for whom the physician decided to prescribe moxifloxacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time until improvement of acute exacerbation	End of study

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: February 18, 2009
• First Submitted That Met QC Criteria: February 18, 2009
• First Posted (Estimate): February 19, 2009

Study Record Updates

• Last Update Posted (Estimate): July 9, 2012
• Last Update Submitted That Met QC Criteria: July 5, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Acute Exacerbation of Chronic Bronchitis (AECB) patients
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Acute Disease; Bronchitis; Bronchitis, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
• Other Study ID Numbers: 14689; 13598 (Company Internal); 13855 (Other Identifier: Company Internal); AX0701 (Other Identifier: Company Internal); 13856 (Company Internal); 13857 (Other Identifier: Company Internal); 14008 (Company Internal); 14007 (Other Identifier: Company Internal); 14009 (Other Identifier: Company Internal)