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

NCT ID: NCT00879008

Last Updated: 2014-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

345 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Chronic Bronchitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Moxifloxacin (Avelox, BAY12-8039)

Intervention Type DRUG

Patients from the normal praxis routine, treated with Moxifloxacin according to the local product information

Interventions

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Moxifloxacin (Avelox, BAY12-8039)

Patients from the normal praxis routine, treated with Moxifloxacin according to the local product information

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Germany

Site Status

Countries

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Germany

Other Identifiers

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AX0710DE

Identifier Type: OTHER

Identifier Source: secondary_id

12629

Identifier Type: -

Identifier Source: org_study_id

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