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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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