Table 1 Baseline demographics and patient characteristics in the per protocol population
CharacteristicsMoxifloxacinAmoxicillin/clavulanic acid
Subjects n538518
Geographic region
 Asia/Pacific162 (30)160 (31)
 Europe188 (35)187 (36)
 South Africa24 (5)11 (2)
 Latin America155 (29)155 (30)
 Canada9 (2)5 (1)
Male425 (79)408 (79)
Race
 Caucasian326 (61)310 (60)
 Asian166 (31)163 (31)
 Other46 (9)45 (9)
Age yrs69.6±6.869.3±6.3
 Range59–9360–88
 ≥65389 (72)378 (73)
BMI kg·m−225.0±5.424.7±4.9
Current smokers113 (24)121 (23)
Coexisting illnesses417 (78)419 (81)
 Coronary artery disease63 (12)43 (8)
 Congestive heart failure25 (5)25 (5)
 Peripheral artery disease11 (2)4 (1)
 Renal dysfunction15 (3)15 (3)
 Liver dysfunction8 (1)11 (2)
 Diabetes mellitus50 (9)53 (10)
Any respiratory co-medication495 (92)475 (92)
 Short-or long-acting β2-agonists292 (54)276 (53)
 Inhaled steroids#283 (53)275 (53)
 Ipratropium or tiotropium241 (45)226 (44)
 Xanthine derivatives176 (33)163 (32)
Previous antimicrobial use190 (35)174 (34)
Systemic steroid use182 (34)189 (36)
 Cumulative dose mg183 (50–350)180 (50–350)
 Duration of steroid therapy days55
Lung function at enrolment
 All patients
  FEV1 % pred39.280±11.62139.186±11.360
  FEV1 L0.982±0.3690.970±0.352
  FEV1 <30% pred139 (26)129 (25)
 Systemic steroid-treated
  FEV1 % pred36.479±11.70436.769±11.007
  FEV1 L0.928±0.3390.920±0.345
  FEV1 <30%54 (30)57 (30)
Exacerbations in previous year2.5±1.12.5±0.9
 ≥3165 (31)152 (29)
Time since last exacerbation days109.6±65.8105.0±62.0
Colour of sputum+
 Yellow327 (61)331 (64)
 Green194 (36)174 (34)
 Rust17 (3)13 (3)
AECB-SS2.2 (0.6)2.2 (0.7)
SGRQ64.9 (18.1)63.5 (18.9)
  • Data are presented as n (%), mean±sd, mean (range) or median, unless otherwise stated. BMI: body mass index; FEV1: forced expiratory volume in 1 s; % pred: % predicted; AECB-SS: Acute Exacerbation of Chronic Bronchitis Symptom Score; SGRQ: St George's Respiratory Questionnaire. #: includes combination therapy (steroid plus bronchodilators);: any antimicrobial given for any indication between 30 and 90 days prior to enrolment; +: identified by colour chart.