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AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00846911
First Posted: February 19, 2009
Last Update Posted: July 9, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  Purpose

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.


Condition Intervention
Bronchitis, Chronic Drug: Moxifloxacin (Avelox, BAY12-8039)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: AVANTI - Avelox® in Acute Exacerbations of Chronic Bronchitis

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Time until improvement of acute exacerbation [ Time Frame: End of study ]

Secondary Outcome Measures:
  • Time until cure of acute exacerbation [ Time Frame: End of study ]
  • Severity of AECB according to Antonisen criteria [ Time Frame: Baseline ]
  • Impact of AECB on daily life activities [ Time Frame: Baseline ]
  • Safety of Avelox under daily life treatment conditions [ Time Frame: Throughout treatment ]

Enrollment: 2672
Study Start Date: April 2008
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Moxifloxacin (Avelox, BAY12-8039)
Patients with acute exacerbation of chronic bronchitis for whom the physician decided to prescribe moxifloxacin

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00846911


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
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Global Medical Affairs Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00846911     History of Changes
Other Study ID Numbers: 14689
AX0701 ( Other Identifier: Company Internal )
13598 ( Other Identifier: Company Internal )
13855 ( Other Identifier: Company Internal )
13856 ( Other Identifier: Company Internal )
13857 ( Other Identifier: Company Internal )
14008 ( Other Identifier: Company Internal )
14007 ( Other Identifier: Company Internal )
14009 ( Other Identifier: Company Internal )
First Submitted: February 18, 2009
First Posted: February 19, 2009
Last Update Posted: July 9, 2012
Last Verified: July 2012

Keywords provided by Bayer:
Acute Exacerbation of Chronic Bronchitis (AECB) patients

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Pulmonary Disease, Chronic Obstructive
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs


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