AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs

• Sponsor: Bayer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00846911
• Collaborator: (none)
• Enrollment: 2,672
• Locations: 8
• Duration (Months): 24
• Patients Per Site: 334
• Patients Per Site Per Month: 13.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchitis, Chronic	Drug: Moxifloxacin (Avelox, BAY12-8039)

Study Design

• Study Type: Observational
• Actual Enrollment: 2672 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: AVANTI - Avelox® in Acute Exacerbations of Chronic Bronchitis
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Apr 1, 2010
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Time until improvement of acute exacerbation [End of study]

Secondary Outcome Measures

1. Time until cure of acute exacerbation [End of study]

2. Severity of AECB according to Antonisen criteria [Baseline]

3. Impact of AECB on daily life activities [Baseline]

4. Safety of Avelox under daily life treatment conditions [Throughout treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1		Many Locations		Albania
2		Many Locations		Bosnia and Herzegovina
3		Many Locations		Kazakhstan
4		Many Locations		Macedonia, The Former Yugoslav Republic of
5		Many Locations		Moldova, Republic of
6		Many Locations		Russian Federation
7		Many Locations		Slovakia
8		Many Locations		Ukraine

Sponsors and Collaborators

• Bayer

Investigators

• Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00846911
• Other Study ID Numbers: 14689; AX0701; 13598; 13855; 13856; 13857; 14008; 14007; 14009
• First Posted: Feb 19, 2009
• Last Update Posted: Jul 9, 2012
• Last Verified: Jul 1, 2012

• Keywords provided by , ,: Acute Exacerbation of Chronic Bronchitis (AECB) patients
• Additional relevant MeSH terms: Bronchitis; Bronchitis, Chronic; Acute Disease; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination

Study Results

No Results Posted as of Jul 9, 2012