check_circleStudy Completed

Bronchitis, Chronic

Bayer Identifier:

14689

ClinicalTrials.gov Identifier:

NCT00846911

EudraCT Number:

Not Available

EU CT Number:

Not Available
AVANTI - Avelox® in Acute exacerbations of chroNic bronchiTIs

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.

Key Participants Requirements

Sex

Both

Age

35 - N/A

  • - 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 must be read in conjunction with the local product information.

Trial summary

Enrollment Goal
2672
Trial Dates
April 2008 - April 2010
Phase
N/A
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Russia
Completed
Many Locations, Moldova
Completed
Many Locations, Kazakhstan
Completed
Many Locations, Macedonia
Completed
Many Locations, Albania
Completed
Many Locations, Slovakia
Completed
Many Locations, Ukraine
Completed
Many Locations, Bosnia And Herzegovina

Primary Outcome

  • Time until improvement of acute exacerbation
    date_rangeTime Frame:
    End of study
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Time until cure of acute exacerbation
    date_rangeTime Frame:
    End of study
    enhanced_encryption
    Safety Issue:
    No
  • Severity of AECB according to Antonisen criteria
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Impact of AECB on daily life activities
    date_rangeTime Frame:
    Baseline
    enhanced_encryption
    Safety Issue:
    No
  • Safety of Avelox under daily life treatment conditions
    date_rangeTime Frame:
    Throughout treatment
    enhanced_encryption
    Safety Issue:
    Yes

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
N/A

Additional Information

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