Chronic BronchitisVICTORNCT00876577
VICTOR - Avelox® Intravenous (i.v.) in Acute Exacerbations of Chronic Bronchitis
An observational study of Chronic Bronchitis and Disease Exacerbation, run by Bayer at 1 site in China.
Trial summary
This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from an acute exacerbation of chronic bronchitis and take at least one dose of Moxifloxacin injection.The primary objective is to obtain clinical effectiveness and safety data of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Bronchitis, Disease Exacerbation
- What is being tested?
- Moxifloxacin (Avelox, BAY12-8039)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 1,206 participants
- Where
- 1 siteChina
- Study dates
- May 2009to Mar 2011
- 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: Adult female and male patients with AECB, who are at least 18 years of age and are scheduled to be treated with Moxifloxacin injection, independent of the duration and severity of the underlying chronic bronchitis, can be documented after the therapy decision has been made.
Who may be able to join
- Patients at least 18 years of age with a diagnosis of AECB treated with Moxifloxacin injection with/without sequential tablet treatment
Who cannot join
- Exclusion criteria must be read in conjunction with the local product information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: VICTOR - Avelox® i.v. in Acute Exacerbations of Chronic Bronchitis
This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from an acute exacerbation of chronic bronchitis and take at least one dose of Moxifloxacin injection.The primary objective is to obtain clinical effectiveness and safety data of Moxifloxacin injection in the treatment of acute exacerbations of chronic bronchitis in patients in whom Moxifloxacin was routinely prescribed. The secondary objective is to find out the possible correlation between the risk factors (sex, smoking, number of previous exacerbations, etc) and AECB, the different treatment effectiveness according to Anthonisen classification. This study will also collect the data of pathogens by sputum culture and the defervescence time of Moxifloxacin injection in treating Acute Exacerbations of Chronic Bronchitis (AECB).
- Conditions
- Chronic Bronchitis, Disease Exacerbation
- Being tested
- Moxifloxacin (Avelox, BAY12-8039)
- Keywords
- Acute Exacerbations of Chronic Bronchitis, 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 injection with/without sequential tablet treatment 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.
clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms
Measured: up to 21 days
Secondary outcomes (4)
Time to cure: time when symptoms are disappeared after Moxifloxacin treatment
Measured: up to 21 days
Improvement time: time when patients feel improvemen
Measured: up to 21 days
Time of patients recover from fever
Measured: up to 21 days
Clinical efficacy rate of Moxifloxacin
Measured: up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2011
- Study completionMar 2011
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
- 1,206 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00876577
- Sponsor's protocol ID
- 14495
- Other IDs
- AX0810CN
- Acronym
- VICTOR
- Status last verified
- Sep 2012
- First submitted
- 3 Apr 2009
- Last updated
- 10 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VICTOR - Avelox® i.v. in Acute Exacerbations of Chronic Bronchitis
- ClinicalTrials.gov ID
- NCT00876577
- Acronym / sponsor ID
- VICTOR / 14495
- Conditions
- Chronic Bronchitis, Disease Exacerbation
- Keywords
- Acute Exacerbations of Chronic Bronchitis, Avelox, Bronchitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,206 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 6 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.
This study is a local, prospective, open-label, company-sponsored, non interventional, multi-center study. Patients documented must suffer from an acute exacerbation of chronic bronchitis and take at least one dose of Moxifloxacin injection.The primary objective is to obtain clinical effectiveness and safety data of Moxifloxacin injection in the treatment of acute exacerbations of chronic bronchitis in patients in whom Moxifloxacin was routinely prescribed. The secondary objective is to find out the possible correlation between the risk factors (sex, smoking, number of previous exacerbations, etc) and AECB, the different treatment effectiveness according to Anthonisen classification. This study will also collect the data of pathogens by sputum culture and the defervescence time of Moxifloxacin injection in treating Acute Exacerbations of Chronic Bronchitis (AECB).
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
- Adult female and male patients with AECB, who are at least 18 years of age and are scheduled to be treated with Moxifloxacin injection, independent of the duration and severity of the underlying chronic bronchitis, can be documented after the therapy decision has been made.
Key inclusion criteria (1 listed)
- Patients at least 18 years of age with a diagnosis of AECB treated with Moxifloxacin injection with/without sequential tablet treatment
Key exclusion criteria (1 listed)
- Exclusion criteria must be read in conjunction with the local product information
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 injection with/without sequential tablet treatment according to the local product information | Drug | Group 1 |
Primary outcome
clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms
Time frame: up to 21 days
4 secondary outcomes
Time to cure: time when symptoms are disappeared after Moxifloxacin treatment
Time frame: up to 21 days
Improvement time: time when patients feel improvemen
Time frame: up to 21 days
Time of patients recover from fever
Time frame: up to 21 days
Clinical efficacy rate of Moxifloxacin
Time frame: up to 21 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 10 Sep 2012.
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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 and Disease Exacerbation, run by Bayer at 1 site in China.
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 1 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 10 Sep 2012. 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 China. 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?
clinical cure rate:clinical cure was defined as disappearance of acute signs and symptoms (time frame: up to 21 days). 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 10 Sep 2012.