NCT00879008

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
345

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 9, 2009

Completed
8 months until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

June 23, 2014

Status Verified

June 1, 2014

Enrollment Period

8 months

First QC Date

April 8, 2009

Last Update Submit

June 20, 2014

Conditions

Chronic Bronchitis

Keywords

Disease ExacerbationAcute Exacerbations of Chronic BronchitisAECBAveloxBronchitis

Outcome Measures

Primary Outcomes (2)

  • Effectiveness and tolerance of/to the different therapies

    within the first 14 days

  • Possible hospitalisation rate

    within the first 14 days

Study Arms (1)

Group 1

Drug: Moxifloxacin (Avelox, BAY12-8039)

Interventions

Moxifloxacin (Avelox, BAY12-8039)DRUG

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

Group 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients who change from one cohort to the other

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Germany

Location

MeSH Terms

Conditions

Bronchitis, ChronicDisease ProgressionBronchitis

Interventions

Moxifloxacin

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesPulmonary Disease, Chronic ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2009

First Posted

April 9, 2009

Study Start

December 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

June 23, 2014

Record last verified: 2014-06

Locations

DE(1)