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Sponsored by: |
Bayer |
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Information provided by: | Bayer |
ClinicalTrials.gov Identifier: | NCT00473460 |
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.
Condition | Intervention | Phase |
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Pulmonary Disease Bronchitis, Chronic |
Drug: Avelox (Moxifloxacin, BAY12-8039) Drug: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Double-Blind, Randomized, Placebo-Controlled Study to Investigate Chronic Intermittent-Pulse-Therapy of Moxifloxacin as a Prevention of Acute in Exacerbation Out-Patients With Chronic Bronchitis. |
Enrollment: | 1402 |
Study Start Date: | October 2004 |
Study Completion Date: | January 2007 |
Arms | Assigned Interventions |
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Arm 1: Experimental |
Drug: Avelox (Moxifloxacin, BAY12-8039)
Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks
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Arm 2: Placebo Comparator |
Drug: Placebo
Matching placebo capsules orally once daily for 5 days every 8 weeks.
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Ages Eligible for Study: | 45 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Bayer Study Director | Bayer |
Responsible Party: | ( Bayer Healthcare Pharmaceuticals Inc., Therapeutic Area Head ) |
Study ID Numbers: | 11229 |
Study First Received: | May 14, 2007 |
Last Updated: | April 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00473460 |
Health Authority: | United States: Food and Drug Administration |
Chronic bronchitis Chronic obstructive pulmonary disease Acute exacerbation of chronic bronchitis Prevention therapy |
Antibiotics Fluoroquinolone Moxifloxacin |
Acute Disease Bronchitis, Chronic Lung Diseases, Obstructive Fluoroquinolones Respiratory Tract Infections Respiratory Tract Diseases |
Moxifloxacin Lung Diseases Respiration Disorders Bronchitis Pulmonary Disease, Chronic Obstructive |
Anti-Infective Agents Disease Attributes Pathologic Processes |
Bronchial Diseases Therapeutic Uses Pharmacologic Actions |