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 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)
Escaldes - Engordany, Andorra
Santiago, Chile
Valparaiso, Chile
MONT-DE-MARSAN 40000, France
NICE 06000, France
ORTHEZ 64300, France
STRASBOURG 67000, France
ROSIERS D'EGLETONS 19300, France
ARRAS 62000, France
Athens 11527, Greece
Dublin 8, Ireland
Tel Aviv 64239, Israel
Afula 18101, Israel
Bat Yam 59512, Israel
Ashkelon 78306, Israel
Pavia 27100, Italy
Milano 20123, Italy
Milano 20157, Italy
Ferrara 44100, Italy
Chihuahua 31350, Mexico
Barcelona 08036, Spain
Madrid 28040, Spain
Valencia 46009, Spain
Tucson, Arizona 85723, United States
Bristol, Avon BS10 5NB, United Kingdom
Badalona, Barcelona 08916, Spain
Kaufbeuren, Bayern / 280 87600, Germany
Berlin, Berlin / 285 10969, Germany
Berlin, Berlin / 285 12043, Germany
Berlin, Berlin / 285 10717, Germany
Florencio Varela, Buenos Aires 1888, Argentina
Long Beach, California 90822-5201, United States
Los Angeles, California 90073-1003, United States
Buenos Aires, Capital Federal C1120AAF, Argentina
Buenos Aires, Capital Federal 1416, Argentina
Buenos Aires, Capital Federal 1426, Argentina
Valladolid, Castilla y León 47010, Spain
Bay Pines, Florida 33744, United States
Bloemfontein, Free State 9301, South Africa
Bloemfontein, Free State 9300, South Africa
Pretoria, Gauteng 0040, South Africa
Pretoria, Gauteng 0157, South Africa
Johannesburg, Gauteng 2057, South Africa
London, Greater London SW17 0QT, United Kingdom
London, Greater London E1 2AT, United Kingdom
London, Greater London NW3 2QG, United Kingdom
Hamburg, Hamburg / 287 20535, Germany
Gelnhausen, Hessen / 307 63571, Germany
Guadalajara, Jalisco 44280, Mexico
Kansas City, Missouri 64128-2295, United States
Ronda, Málaga 29400, Spain
Buffalo, New York 14215-1129, United States
Hannover, Niedersachsen / 291 30159, Germany
Witten, Nordrhein-Westfalen / 361 58452, Germany
Rio, Patras 265 00, Greece
Porto Alegre, RS 90610-000, Brazil
Neuwied, Rheinland-Pfalz / 381 56564, Germany
Sao Paulo, SP 05403-900, Brazil
Sao Paulo, SP 04023-900, Brazil
Bad Segeberg, Schleswig-Holstein / 306 23795, Germany
Houston, Texas 77030-4298, United States
San Antonio, Texas 78284-5799, United States
Dallas, Texas 75216-7167, United States
Richmond, Virginia 23249-0002, United States
Birmingham, West Midlands B15 2TH, United Kingdom
Leeds, West Yorkshire LS9 7TF, United Kingdom
Cape Town, Western Cape 7531, South Africa
Cape Town, Western Cape 7569, South Africa
Paarl, Western Cape 7646, South Africa
Mérida, Yucatán 97070, Mexico
Mérida, Yucatán 97001, Mexico
Juiz de Fora, mg 36036-110, Brazil
