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:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00879008
First received: April 8, 2009
Last updated: November 1, 2011
Last verified: November 2011
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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: | 335 |
| 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 More Information
Additional Information:
No publications provided
| Responsible Party: | Medical Director, Bayer Vital GmbH |
| ClinicalTrials.gov Identifier: | NCT00879008 History of Changes |
| Other Study ID Numbers: | 12629, AX0710DE |
| Study First Received: | April 8, 2009 |
| Last Updated: | November 1, 2011 |
| 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 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-Infective Agents Therapeutic Uses Pharmacologic Actions Contraceptives, Oral, Combined Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 21, 2013