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

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ClinicalTrials.gov Identifier: NCT00879008
Recruitment Status : Completed
First Posted : April 9, 2009
Last Update Posted : June 23, 2014
Sponsor:
Information provided by (Responsible Party):
Bayer

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.

Condition or disease Intervention/treatment
Chronic Bronchitis Drug: Moxifloxacin (Avelox, BAY12-8039)

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.

Study Type : Observational
Actual Enrollment : 345 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe AECB
Study Start Date : December 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Group 1 Drug: Moxifloxacin (Avelox, BAY12-8039)
Patients from the normal praxis routine, treated with Moxifloxacin according to the local product information



Primary Outcome Measures :
  1. Effectiveness and tolerance of/to the different therapies [ Time Frame: within the first 14 days ]
  2. Possible hospitalisation rate [ Time Frame: within the first 14 days ]

Biospecimen Retention:   None Retained
n.a.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00879008


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00879008     History of Changes
Other Study ID Numbers: 12629
AX0710DE ( Other Identifier: Company Internal )
First Posted: April 9, 2009    Key Record Dates
Last Update Posted: June 23, 2014
Last Verified: June 2014

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

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