check_circleStudy Completed

Chronic Bronchitis

Bayer Identifier:

12629

ClinicalTrials.gov Identifier:

NCT00879008

EudraCT Number:

Not Available

EU CT Number:

Not Available
SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe Acute Exacerbations of Chronic Bronchitis (AECB)

Trial purpose

In this study data of patients with moderate or severe acute exacerbations of chronic bronchitis (AECB) were collected. There were two different cohorts which were compared (Moxifloxacin and other antibiotics) concerning effectiveness and tolerance. It was a prospective study which was accomplished in 100 ambulatory practice offices.

Key Participants Requirements

Sex

Both

Age

18 - N/A

  • - Acute exacerbation of chronic bronchitis from Anthonisen type I or II
    - FEV1 of < 50 %
    - Patient must be ensured in the statutory health insurance
    - Further contraindications of the prescribed pharmaceutical products must be considered


  • - Patients who change from one cohort to the other

Trial summary

Enrollment Goal
345
Trial Dates
December 2009 - August 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, Germany

Primary Outcome

  • Effectiveness and tolerance of/to the different therapies
    date_rangeTime Frame:
    within the first 14 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Possible hospitalisation rate
    date_rangeTime Frame:
    within the first 14 days
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe AECB
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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