Intermittent Moxifloxacin Therapy For The Prevention Of Acute Exacerbations In Patients With Chronic Bronchitis
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, 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.
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
 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 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)