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NCT00879008 Clinical Trial

SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe Acute Exacerbations of Chronic Bronchitis (AECB)

Chronic Bronchitis Clinical Trial

— SYMPROVE III  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00879008
Other study ID # 12629
Secondary ID AX0710DE
Status Completed
Phase N/A
First received April 8, 2009
Last updated June 20, 2014
Start date December 2009
Est. completion date August 2010

Study information
Verified date June 2014
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

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.

Description:

The study design was slightly changed to adapt the target population. Due to these changes the study was restarted on 8th December 2009.

Recruitment information / eligibility
Status Completed
Enrollment 345
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Patients who change from one cohort to the other

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Moxifloxacin (Avelox, BAY12-8039)
Patients from the normal praxis routine, treated with Moxifloxacin according to the local product information

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effectiveness and tolerance of/to the different therapies within the first 14 days Yes
Primary Possible hospitalisation rate within the first 14 days Yes
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