Avelox® in Acute Exacerbations of chroNic bronchiTIs - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00846911

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	Phase
Bronchitis, Chronic	Drug: Avelox (Moxifloxacin, BAY12-8039)	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Bronchitis

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Time until improvement of acute exacerbation [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

n.a

Estimated Enrollment:	2990
Study Start Date:	June 2008
Estimated Study Completion Date:	April 2010
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Group 1	Drug: Avelox (Moxifloxacin, BAY12-8039) Patients with acute exacerbation of chronic bronchitis for whom the physician decided to prescribe moxifloxacin

Eligibility

Ages Eligible for Study:	35 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846911

Contacts

Contact: Bayer Clinical Trials Contact

clinical-trials-contact@bayerhealthcare.com

Locations

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

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA This link exits the ClinicalTrials.gov site

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product This link exits the ClinicalTrials.gov site

Click here to find results for studies related to marketed products This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Global Medical Affairs Head )
Study ID Numbers:	14689, AX0701, AVANTI, 13598, 13855, 13856, 13857, 14008, 14007, 14009
Study First Received:	February 18, 2009
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00846911 History of Changes
Health Authority:	Albania: Ministry of Health Department of Pharmacy; Bosnia and Herzegovina: Federal Ministry of Health; Kazakhstan: Ethical Commission; Moldova: Ministry of Health; Macedonia: Ministry of Health; Russia: Ethics Committee; Slovakia: State Institute for Drug Control; Ukraine: Central Ethical Comission

Keywords provided by Bayer:

Acute Exacerbation of Chronic Bronchitis (AECB) patients

Additional relevant MeSH terms:

Acute Disease
Anti-Infective Agents
Disease Attributes
Bronchial Diseases
Pharmacologic Actions
Bronchitis, Chronic
Lung Diseases, Obstructive
Pathologic Processes

Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Therapeutic Uses
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on February 08, 2010