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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 (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00879008
First received: April 8, 2009
Last updated: June 20, 2014
Last verified: June 2014
  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.


Condition Intervention
Chronic Bronchitis
Drug: Moxifloxacin (Avelox, BAY12-8039)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe AECB

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

n.a.


Enrollment: 345
Study Start Date: December 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Moxifloxacin (Avelox, BAY12-8039)
Patients from the normal praxis routine, treated with Moxifloxacin according to the local product information

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00879008

Locations
Germany
Many Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00879008     History of Changes
Other Study ID Numbers: 12629, AX0710DE
Study First Received: April 8, 2009
Last Updated: June 20, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Disease Exacerbation
Acute Exacerbations of Chronic Bronchitis
AECB
Avelox
Bronchitis

Additional relevant MeSH terms:
Bronchitis
Bronchitis, Chronic
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Antineoplastic Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 27, 2014