Table 1– Demographic and baseline data (modified intent-to-treat/safety population)
CharacteristicCiprofloxacin DPIPlacebo
Subjects n6064
Age years64.7±11.861.4±11.9
Sex
 Male21 (35.0)21 (32.8)
 Female39 (65.0)43 (67.2)
Ethnicity
 Caucasian60 (100.0)63 (98.4)
 Asian01 (1.6)
Weight kg70.2±16.469.1±17.2
BMI kg·m−225.6±5.525.1±5.6
FEV1 % pred57.2±13.754.6±14.8
Subjects with exacerbations in previous 12 months
 1–2 exacerbations30 (50.0)35 (54.7)
 3–4 exacerbations25 (41.7)26 (40.6)
 ≥5 exacerbations5 (8.3)3 (4.7)
Baseline total bacterial load log10 CFU·g−17.19±1.946.92±1.90
Baseline bacterial isolates in ≥5% subjects#
Pseudomonas aeruginosa32 (53.3)35 (54.7)
Haemophilus influenzae14 (23.3)16 (25.0)
Staphylococcus aureus8 (13.3)17 (26.6)
Streptococcus pneumoniae7 (11.7)2 (3.1)
Moraxella catarrhalis5 (8.3)3 (4.7)
Klebsiella pneumoniae5 (8.3)0
Proteus mirabilis3 (5.0)4 (6.3)
Klebsiella oxytoca3 (5.0)2 (3.1)
  • Data are presented as mean±sd or n (%), unless otherwise stated. DPI: dry powder for inhalation; BMI: body mass index; FEV1: forced expiratory volume in 1 s; % pred: % predicted. #: no significant differences between ciprofloxacin DPI and placebo for isolates were reported apart from for K. pneumoniae (p=0.024).