check_circleStudy Completed

Chronic Bronchitis, Disease Exacerbation

Bayer Identifier:

14495

ClinicalTrials.gov Identifier:

NCT00876577

EudraCT Number:

Not Available

EU CT Number:

Not Available
VICTOR - Avelox® intravenous (i.v.) in Acute Exacerbations of Chronic Bronchitis

Trial purpose

This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from an acute exacerbation of chronic bronchitis and take at least one dose of Moxifloxacin injection.The primary objective is to obtain clinical effectiveness and safety data of Moxifloxacin injection in the treatment of acute exacerbations of chronic bronchitis in patients in whom Moxifloxacin was routinely prescribed. The secondary objective is to find out the possible correlation between the risk factors (sex, smoking, number of previous exacerbations, etc) and AECB, the different treatment effectiveness according to Anthonisen classification. This study will also collect the data of pathogens by sputum culture and the defervescence time of Moxifloxacin injection in treating Acute Exacerbations of Chronic Bronchitis (AECB).

Key Participants Requirements

Sex

Both

Age

18 - N/A
  • - Patients at least 18 years of age with a diagnosis of AECB treated with Moxifloxacin injection with/without sequential tablet treatment

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

Trial summary

Enrollment Goal
1206
Trial Dates
May 2009 - March 2011
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, China

Primary Outcome

  • clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms
    date_rangeTime Frame:
    up to 21 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Time to cure: time when symptoms are disappeared after Moxifloxacin treatment
    date_rangeTime Frame:
    up to 21 days
    enhanced_encryption
    Safety Issue:
    No
  • Improvement time: time when patients feel improvemen
    date_rangeTime Frame:
    up to 21 days
    enhanced_encryption
    Safety Issue:
    No
  • Time of patients recover from fever
    date_rangeTime Frame:
    up to 21 days
    enhanced_encryption
    Safety Issue:
    No
  • Clinical efficacy rate of Moxifloxacin
    date_rangeTime Frame:
    up to 21 days
    enhanced_encryption
    Safety Issue:
    No

Trial design

VICTOR - Avelox® i.v. 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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