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.”

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 2: Receives a matching placebo once daily for five days. In between each visit (four weeks after your clinic visit), the study site co-ordinator will contact the patient to check on his well being. If the patient or the doctor decides to stop the patients participation in the trial for any reason, the patient will be required to return to the clinic for a physical examination, take a breath test, provide a sputum sample (if possible) and have a blood sample taken.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Avelox (Moxifloxacin, BAY12-8039)
  • Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks
• Drug: Placebo
  • Matching placebo capsules orally once daily for 5 days every 8 weeks.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Placebo Comparator: Arm 2

Primary Measures

• Number of exacerbations after 48 weeks of intermittent pulse treatment
  • Time Frame: After 48 weeks of treatment
    

Secondary Measures

• Impact of treatment on the health related Quality of Life in St. George's Respiratory Questionaire (SGRQ) scores
  • Time Frame: At week 48
    
• Deterioration in lung function test (PFEV1)
  • Time Frame: At week 48
    
• Frequency of hospitalisation
  • Time Frame: At week 48
    
• Mortality rates
  • Time Frame: At week 48
    
• Time of first exacerbation
  • Time Frame: Through to week 48
    
• Frequency of acute exacerbation of chronic bronchitis
  • Time Frame: At week 24 and 72 (end of follow-up)
    
• Time to next exacerbation from last pulsed dose
  • Time Frame: At week 48
    
• Length of exacerbations
  • Time Frame: Through to week 48
    
• Percentage of exacerbation free time
  • Time Frame: Through to week 48
    

Inclusion Criteria:

• 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 months
• If 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 Criteria:

• 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)

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00473460

Study ID Number: 11229

ClinicalTrials.gov Identifier: NCT00473460

Health Authority: United States: Food and Drug Administration

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