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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00879008
First received: April 8, 2009
Last updated: June 20, 2013
Last verified: June 2013

April 8, 2009
June 20, 2013
December 2009
August 2010   (final data collection date for primary outcome measure)
  • Effectiveness and tolerance of/to the different therapies [ Time Frame: within the first 14 days ] [ Designated as safety issue: Yes ]
  • Possible hospitalisation rate [ Time Frame: within the first 14 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00879008 on ClinicalTrials.gov Archive Site
Not Provided
  • Possible hospitalisation rate [ Time Frame: within the first 14 days ] [ Designated as safety issue: Yes ]
  • Exacerbation-free time-intervals [ Time Frame: 6 month after beginning of the study ] [ Designated as safety issue: Yes ]
  • The quality of life [ Time Frame: within the first 14 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe Acute Exacerbations of Chronic Bronchitis (AECB)
SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe AECB

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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

n.a.

Non-Probability Sample

It is a multicentre study in the ambulatory sector. Every primary care physician or pulmologist should inclose the first 5 patients with AECB from Anthonisen type I or II

Chronic Bronchitis
Drug: Moxifloxacin (Avelox, BAY12-8039)
Patients from the normal praxis routine, treated with Moxifloxacin according to the local product information
Group 1
Intervention: Drug: Moxifloxacin (Avelox, BAY12-8039)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
345
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00879008
12629, AX0710DE
No
Medical Director, Bayer Vital GmbH
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP