- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00879008
SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe Acute Exacerbations of Chronic Bronchitis (AECB) (SYMPROVE III)
June 20, 2014 updated by: Bayer
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Enrollment (Actual)
345
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Many Locations, Germany
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Group 1
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Patients from the normal praxis routine, treated with Moxifloxacin according to the local product information
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Effectiveness and tolerance of/to the different therapies
Time Frame: within the first 14 days
|
within the first 14 days
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Possible hospitalisation rate
Time Frame: within the first 14 days
|
within the first 14 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
April 8, 2009
First Submitted That Met QC Criteria
April 8, 2009
First Posted (Estimate)
April 9, 2009
Study Record Updates
Last Update Posted (Estimate)
June 23, 2014
Last Update Submitted That Met QC Criteria
June 20, 2014
Last Verified
June 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Disease Attributes
- Bronchial Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Acute Disease
- Bronchitis
- Bronchitis, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Anti-Bacterial Agents
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptives, Oral, Combined
- Contraceptives, Oral
- Contraceptive Agents, Female
- Moxifloxacin
- Norgestimate, ethinyl estradiol drug combination
Other Study ID Numbers
- 12629
- AX0710DE (Other Identifier: Company Internal)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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