Status:
COMPLETED
Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis
Lead Sponsor:
Bayer
Conditions:
Lung Diseases
Bronchitis, Chronic
Eligibility:
All Genders
45-90 years
Phase:
PHASE3
Brief 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 reducin...
Eligibility Criteria
Inclusion
- Male or female out-patients \>/= 45 years
- Subjects suffering from chronic bronchitis
- FEV1\</= 70% and FEV1/FVC \</= 70% predicted from age, height and sex
- No documented episode of AECB (requiring treatment) within 6 weeks of randomization and not experiencing an exacerbation at the time of screening
- Sputum production on most days, even when exacerbation free
- Subjects presented with at least two documented (i.e. requiring antibiotics and/or systemic steroid administration) acute exacerbation episodes during the last 12 monthsIf receiving chronic therapy with inhaled long acting bronchodilators and/or inhaled or systemic steroids, the treatment must have remained stable for the preceding 6 weeks prior to screening
- Smoking history of at least 20 pack-years
- Subjects willing and able to give fully informed written consent
Exclusion
- Subjects with contra-indications to moxifloxacin- Known bronchial carcinoma, pulmonary tuberculosis, cystic fibrosis, documented chronic bronchial asthma or diffuse bronchiectasis- Subjects who are actively participating in intensive pulmonary rehabilitation programs
- Subjects with a known history of chronic colonization of pathogenic organisms resistant to moxifloxacin, e.g. Pseudomonas spp, MRSA
- No systemic or inhaled antibiotic therapy during the 6 weeks prior to screening and any long term antibiotic usage
- Subjects requiring home ventilatory support for COPD and those who have a tracheostomy in situ (subjects requiring home/potable oxygen therapy or CPAP for sleep apnea can be included)
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2007
Estimated Enrollment :
1404 Patients enrolled
Trial Details
Trial ID
NCT00473460
Start Date
October 1 2004
End Date
January 1 2007
Last Update
October 28 2014
Active Locations (78)
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1
Tucson, Arizona, United States, 85723
2
Long Beach, California, United States, 90822-5201
3
Los Angeles, California, United States, 90073-1003
4
Bay Pines, Florida, United States, 33744