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NCT00473460 · ClinicalTrials.gov registry record · Phase 3
Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,404
- Enrollment target
NCT00473460: Completed Phase 3 study, sponsored by Bayer.
NCT00473460 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 1,404 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00473460, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,404 participants
- Enrollment target
Study Summary
Moxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine if this drug, when taken periodically in addition to the patients normal treatment, is effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately 1132 subjects will participate, and it is expected that the study will run for 2 years in order to reach that goal. The patients individual involvement in the study will be 17 months. Moxifloxacin will be compared to a placebo drug (no active ingredients). The study medication (moxifloxacin or placebo) will be taken in addition to the patients normal medication for chronic bronchitis. In addition to the first clinic visit, called a screening visit, the patient will be required to come back to the clinic for ten more study visits, every 8 weeks. At the first visit the study co-ordinator will provide him with the dates for all the visits. Over a period of 48 weeks the patient will return to the clinic on 6 occasions where he will receive the study medication which he will take for five days, in addition to his normal treatment for chronic bronchitis. After this time the patient will enter a follow up period for 24 weeks, where he will come to the clinic for assessments and continue to take his normal medication but not receive the study drug. A complete medical history will be taken at the first visit, including the patients past and current smoking habit. A breath test will be performed to assess how well his lungs are functioning. In addition, he will also be asked to provide a sputum sample for a microbiological examination to identify any bacteria present in the sample. The patient must be able to provide a sputum sample at the screening visit. If the patient meets all the inclusion / exclusion criteria for the study, he will be allocated randomly to one of the following treatment groups at the second visit.- Treatment group 1: Receives moxifloxacin orally once daily for five days.- Treatment group
Interventions
- DRUG Placebo
- DRUG Avelox (Moxifloxacin, BAY12-8039)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,404 participants |
| Start Date | 2004-10 |
| Est. Completion | 2007-01 |
| Phase | Phase 3 |
What the finished NCT00473460 record still lists
NCT00473460 is an interventional study that assigns participants to a tested intervention. Its 1,404 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00473460 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00473460 about?
NCT00473460 is a clinical study titled "Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis". Moxifloxacin, is being tested at approximately 60 study centres in 15 countries to determine if this drug, when taken periodically in addition to the patients normal treatment, is effective at reducing the number of flare-ups of chronic bronchitis he has. Approximately 1132 subjects will participate...
What is the current status of trial NCT00473460?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,404 participants. The study started on 2004-10. Estimated completion is 2007-01.
What interventions are being tested in trial NCT00473460?
The interventions under investigation include: Placebo (DRUG), Avelox (Moxifloxacin, BAY12-8039) (DRUG).
Who is sponsoring clinical trial NCT00473460?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00473460's enrollment target sits among peer trials
1,404 172nd of 2000 higher than 1,829 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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