Trial Condition(s):
Bronchitis, Chronic
AVANTI - Avelox® in Acute exacerbations of chroNic bronchiTIs
Bayer Identifier:
14689
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial 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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Many Locations, Russia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Moldova | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Kazakhstan | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Macedonia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Albania | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Slovakia | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Ukraine | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Bosnia and Herzegovina | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
AVANTI - Avelox® in Acute Exacerbations of chronic bronchitis
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Time until improvement of acute exacerbationTimeframe: End of study
Secondary Outcome
- Time until cure of acute exacerbationTimeframe: End of study
- Severity of AECB according to Antonisen criteriaTimeframe: Baseline
- Impact of AECB on daily life activitiesTimeframe: Baseline
- Safety of Avelox under daily life treatment conditionsTimeframe: Throughout treatment
Additional Information
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