Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis
Condition: Lung Diseases; Bronchitis, Chronic
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Acute Disease
Study type: Interventional
Phase: Phase 3

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 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.
    


Intervention name(s): Avelox (Moxifloxacin, BAY12-8039); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Avelox (Moxifloxacin, BAY12-8039), 400 mg capsules orally once daily for 5 days every 8 weeks; Matching placebo capsules orally once daily for 5 days every 8 weeks.
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Chronic bronchitis; Chronic obstructive pulmonary disease; Acute exacerbation of chronic bronchitis; Prevention therapy; Antibiotics; Fluoroquinolone; Moxifloxacin; AECB