Chronic BronchitisSYMPROVE IIINCT00879008
SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe Acute Exacerbations of Chronic Bronchitis (AECB)
An observational study of Chronic Bronchitis, run by Bayer at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Bronchitis
- What is being tested?
- Moxifloxacin (Avelox, BAY12-8039)
- How many people
- 345 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients who change from one cohort to the other
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Bronchitis
- Being tested
- Moxifloxacin (Avelox, BAY12-8039)
- Keywords
- Disease Exacerbation, Acute Exacerbations of Chronic Bronchitis, AECB, Avelox, Bronchitis
- Medical subject headings
- Bronchitis, Chronic, Disease Progression, Bronchitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin (Avelox, BAY12-8039)Drug
Patients from the normal praxis routine, treated with Moxifloxacin according to the local product information
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Moxifloxacin (Avelox, BAY12-8039) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness and tolerance of/to the different therapies
Measured: within the first 14 days
Possible hospitalisation rate
Measured: within the first 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2009 (estimated)
- Study startDec 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic BronchitisStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00879008
- Sponsor's protocol ID
- 12629
- Other IDs
- AX0710DE
- Acronym
- SYMPROVE III
- Status last verified
- Jun 2014
- First submitted
- 8 Apr 2009
- Last updated
- 23 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SYMPROVE III: Health Services Research Study for Treatment of the Moderate and Severe AECB
- ClinicalTrials.gov ID
- NCT00879008
- Acronym / sponsor ID
- SYMPROVE III / 12629
- Conditions
- Chronic Bronchitis
- Keywords
- Disease Exacerbation, Acute Exacerbations of Chronic Bronchitis, AECB, Avelox, Bronchitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Moxifloxacin (Avelox, BAY12-8039) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who change from one cohort to the other
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxifloxacin (Avelox, BAY12-8039)Patients from the normal praxis routine, treated with Moxifloxacin according to the local product information | Drug | Group 1 |
Primary outcome
Effectiveness and tolerance of/to the different therapies
Time frame: within the first 14 days
Possible hospitalisation rate
Time frame: within the first 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Bronchitis, run by Bayer at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness and tolerance of/to the different therapies (time frame: within the first 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2014.