TABLE 1

Patient demographics and baseline characteristics

Ciprofloxacin DPI
14days on/off
Placebo
14days on/off
Ciprofloxacin DPI
28days on/off
Placebo
28days on/off
Pooled placeboTotal
Patients n1376814170138416
Female88 (64.2)44 (64.7)101 (71.6)52 (74.3)96 (69.6)285 (68.5)
Age years65.2±13.565.5±12.964.2±12.164.0±13.564.8±13.264.7±12.9
Idiopathic aetiology81 (59.1)43 (63.2)70 (49.6)32 (45.7)75 (54.3)226 (54.3)
Region#
 Europe 136 (26.3)18 (26.5)35 (24.8)18 (25.7)36 (26.1)107 (25.7)
 Europe 241 (29.9)20 (29.4)42 (29.8)20 (28.6)40 (29.0)123 (29.6)
 USA14 (10.2)9 (13.2)14 (9.9)7 (10.0)16 (11.6)44 (10.6)
 Latin America1 (0.7)0 (0)3 (2.1)2 (2.9)2 (1.4)6 (1.4)
 Japan11 (8.0)4 (5.9)12 (8.5)6 (8.6)10 (7.2)33 (7.9)
 Australia/New Zealand34 (24.8)17 (25.0)35 (24.8)17 (24.3)34 (24.6)103 (24.8)
Ethnicity
 White115 (83.9)60 (88.2)124 (87.9)64 (91.4)124 (89.9)363 (87.3)
 Black2 (1.5)1 (1.5)1 (0.7)01 (0.7)4 (1.0)
 Asian12 (8.8)4 (5.9)12 (8.5)6 (8.6)10 (7.2)34 (8.2)
 American Indian001 (0.7)001 (0.2)
 Native Hawaiian5 (3.6)1 (1.5)2 (1.4)01 (0.7)8 (1.9)
 Not reported3 (2.2)2 (2.9)1 (0.7)02 (1.4)6 (1.4)
FEV1 % pred59.42±16.757.37±15.559.48±15.161.7±16.7NC59.50±16.0
FEV1 % pred <50%41 (29.9)22 (32.4)44 (31.2)18 (25.7)40 (29.0)125 (30.0)
SGRQ symptoms component score52.51±21.4858.72±20.4060.72±19.4755.52±22.07NC56.84±20.95
QOL-B RSS57.69±18.7250.67±19.5953.01±18.7155.82±18.04NC54.57±18.87
Exacerbations in prior 12months3.0±1.52.8±1.12.9±1.32.9±1.32.8±1.22.9±1.4
Three or more exacerbations in
prior 12months
63 (46.0)29 (42.6)62 (44.0)33 (47.1)62 (44.9)187 (45.0)
Hospitalised for exacerbation in
prior year
30 (21.9)15 (22.1)28 (19.9)18 (25.7)33 (23.9)91 (21.9)
Long-term oral macrolides24 (17.5)8 (11.8)22 (15.6)12 (17.1)20 (14.5)66 (15.9)
History of COPD23 (16.8)15 (22.1)20 (14.2)8 (11.4)23 (16.7)66 (15.9)
Baseline Pseudomonas
aeruginosa
83 (60.6)41 (60.3)83 (58.9)45 (64.3)86 (62.3)252 (60.6)

Data are presented as n (%) or mean±sd, unless otherwise stated. DPI: dry powder for inhalation; FEV1: forced expiratory volume in 1 s; SGRQ: St George's Respiratory Questionnaire; QOL-B RSS: Quality of Life-Bronchiectasis respiratory symptoms domain score; COPD: chronic obstructive pulmonary disease; NC: not calculated. #: Europe 1: Denmark, France, Germany, Latvia, Slovakia, UK; Europe 2: Israel, Italy, Spain; Latin America: Argentina. : patients could have more than one species isolated.