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NCT00846911 Clinical Trial

AVANTI - Avelox® in Acute Exacerbations of chroNic bronchiTIs

Bronchitis, Chronic Clinical Trial

Official title:
AVANTI - Avelox® in Acute Exacerbations of Chronic Bronchitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00846911
Other study ID # 14689
Secondary ID AX07011359813855
Status Completed
Phase N/A
First received February 18, 2009
Last updated July 5, 2012
Start date April 2008
Est. completion date April 2010

Study information
Verified date July 2012
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Albania: Ministry of Health Department of PharmacyBosnia: Federal Ministry of HealthKazakhstan: Ethical CommissionMoldova: Ministry of HealthMacedonia: Ministry of HealthRussia: Ethics CommitteeSlovakia: State Institute for Drug ControlUkraine: Central Ethical Comission
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2672
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 35 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Moxifloxacin (Avelox, BAY12-8039)
Patients with acute exacerbation of chronic bronchitis for whom the physician decided to prescribe moxifloxacin

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

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

Outcome
Type Measure Description Time frame Safety issue
Primary Time until improvement of acute exacerbation End of study No
Secondary Time until cure of acute exacerbation End of study No
Secondary Severity of AECB according to Antonisen criteria Baseline No
Secondary Impact of AECB on daily life activities Baseline No
Secondary Safety of Avelox under daily life treatment conditions Throughout treatment Yes
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Completed NCT00257140 - A Study of the Safety and Effectiveness of Levofloxacin Compared With Cefaclor in the Treatment of Adults With Chronic Bronchitis Experiencing Rapid Onset of Worsening of Symptoms Caused by Bacteria Phase 2/Phase 3
Completed NCT01719822 - Physical Activity Augmentation Using Pedometers During Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease N/A
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Completed NCT01077102 - Eccentric Exercise Training as Novel Rehabilitation for Chronic Obstructive Pulmonary Disease (COPD) N/A
Terminated NCT00288223 - Telithromycin in Acute Exacerbation of Chronic Bronchitis Phase 4
Completed NCT00644449 - A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Acute Symptoms of Chronic Bronchitis Phase 3
Completed NCT00423137 - Effect of BIBW 2948 BS in COPD Phase 2
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Completed NCT00932802 - Greatest International Antiinfective Trial With Avelox N/A
Completed NCT00245427 - Outcomes of Patients Not Responding to Antibiotics in the Community N/A
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