Bronchitis, ChronicGIANTNCT00932802
Greatest International Antiinfective Trial With Avelox
An observational study of Bronchitis, Chronic and Bronchial Diseases, run by Bayer at 24 sites in 24 countries.
Trial summary
The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Bronchitis, Chronic, Bronchial Diseases
- What is being tested?
- Moxifloxacin (Avelox, BAY12-8039)
- How many people
- 50,000 participants
- Where
- 24 sitesin 24 countries
- Study dates
- Feb 2004to Nov 2007
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a diagnosis of AECB who take moxifloxacin
Who may be able to join
- Outpatients with diagnosis of AECB and decision taken by the investigator to prescribe moxifloxacin
Who cannot join
- Exclusion criteria must be read in conjunction with the local product information
Trial locations and contacts
24 sites in 24 countries.
24 sites in 24 countries
About this study
Official title: GIANT - Greatest International Antiinfective Trial With Avelox®
The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.
- Conditions
- Bronchitis, Chronic, Bronchial Diseases
- Being tested
- Moxifloxacin (Avelox, BAY12-8039)
- Keywords
- Non-Interventional, Observational, NIS, Moxifloxacin, MXF, Avelox, AECB
- Medical subject headings
- Bronchitis, Chronic, Bronchial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin (Avelox, BAY12-8039)Drug
AECB patients under daily life treatment receiving 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.
Evaluation of impact of AECB on the patient and the community as well as effect and safety of a treatment with moxifloxacin tablets in daily life clinical practice
Measured: During documentation at baseline and at at least one short-term follow-up visit; at maximum two short-term (within ca. 14 days) and two long-term follow-up visits (after ca. 6 and 12 months).
Secondary outcomes (5)
Course of symptom relief
Measured: During documentation of up to two short-term follow-up visits (within ca. 14 days)
Speed of return to normal daily life activities
Measured: During documentation of the last short-term follow-up visit (after ca. 14 days)
Adverse events collection
Measured: Throughout the entire study, whenever Adverse Events occur
Evaluation of frequency of new exacerbations
Measured: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
Progression of chronic respiratory disease
Measured: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startFeb 2004
- Primary completionNov 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchitis, ChronicStudies 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
- 50,000 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
- NCT00932802
- Sponsor's protocol ID
- 12219
- Other IDs
- AX0401, 11828, 12206, 12214, 12234, 12213, 12212, 12216
- Acronym
- GIANT
- Status last verified
- Nov 2012
- First submitted
- 2 Jul 2009
- Last updated
- 19 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anzueto A, Miravitlles M, Ewig S, Legnani D, Heldner S, Stauch K. Identifying patients at risk of late recovery (>/= 8 days) from acute exacerbation of chronic bronchitis and COPD. Respir Med. 2012 Sep;106(9):1258-67. doi: 10.1016/j.rmed.2012.06.002. Epub 2012 Jun 30.
PubMed 22749710
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GIANT - Greatest International Antiinfective Trial With Avelox®
- ClinicalTrials.gov ID
- NCT00932802
- Acronym / sponsor ID
- GIANT / 12219
- Conditions
- Bronchitis, Chronic, Bronchial Diseases
- Keywords
- Non-Interventional, Observational, NIS, Moxifloxacin, MXF, Avelox, AECB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50,000 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Feb 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 3 Jul 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.
The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.
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
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a diagnosis of AECB who take moxifloxacin
Key inclusion criteria (1 listed)
- Outpatients with diagnosis of AECB and decision taken by the investigator to prescribe moxifloxacin
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)AECB patients under daily life treatment receiving moxifloxacin according to the local product information. | Drug | Group 1 |
Primary outcome
Evaluation of impact of AECB on the patient and the community as well as effect and safety of a treatment with moxifloxacin tablets in daily life clinical practice
Time frame: During documentation at baseline and at at least one short-term follow-up visit; at maximum two short-term (within ca. 14 days) and two long-term follow-up visits (after ca. 6 and 12 months).
5 secondary outcomes
Course of symptom relief
Time frame: During documentation of up to two short-term follow-up visits (within ca. 14 days)
Speed of return to normal daily life activities
Time frame: During documentation of the last short-term follow-up visit (after ca. 14 days)
Adverse events collection
Time frame: Throughout the entire study, whenever Adverse Events occur
Evaluation of frequency of new exacerbations
Time frame: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
Progression of chronic respiratory disease
Time frame: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months)
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 19 Nov 2012.
- Results publication: PubMed 22749710Anzueto A, Miravitlles M, Ewig S, Legnani D, Heldner S, Stauch K. Identifying patients at risk of late recovery (>/= 8 days) from acute exacerbation of chronic bronchitis and COPD. Respir Med. 2012 Sep;106(9):1258-67. doi: 10.1016/j.rmed.2012.06.002. Epub 2012 Jun 30.
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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
24 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchitis, Chronic and Bronchial Diseases, run by Bayer at 24 sites in 24 countries.
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 19 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Austria, Brazil, China, Colombia, Croatia and 19 more countries. 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?
Evaluation of impact of AECB on the patient and the community as well as effect and safety of a treatment with moxifloxacin tablets in daily life clinical practice (time frame: During documentation at baseline and at at least one short-term follow-up visit; at maximum two short-term (within ca. 14 days) and two long-term follow-up visits (after ca. 6 and 12 months).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00932802, which also lists 1 linked publication.
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 19 Nov 2012.