Ciprofloxacin DPI 14 days on/off | Placebo 14 days on/off | Ciprofloxacin DPI 28 days on/off | Placebo 28 days on/off | Pooled placebo | Total | |
Patients n | 137 | 68 | 141 | 70 | 138 | 416 |
Female | 88 (64.2) | 44 (64.7) | 101 (71.6) | 52 (74.3) | 96 (69.6) | 285 (68.5) |
Age years | 65.2±13.5 | 65.5±12.9 | 64.2±12.1 | 64.0±13.5 | 64.8±13.2 | 64.7±12.9 |
Idiopathic aetiology | 81 (59.1) | 43 (63.2) | 70 (49.6) | 32 (45.7) | 75 (54.3) | 226 (54.3) |
Region# | ||||||
Europe 1 | 36 (26.3) | 18 (26.5) | 35 (24.8) | 18 (25.7) | 36 (26.1) | 107 (25.7) |
Europe 2 | 41 (29.9) | 20 (29.4) | 42 (29.8) | 20 (28.6) | 40 (29.0) | 123 (29.6) |
USA | 14 (10.2) | 9 (13.2) | 14 (9.9) | 7 (10.0) | 16 (11.6) | 44 (10.6) |
Latin America | 1 (0.7) | 0 (0) | 3 (2.1) | 2 (2.9) | 2 (1.4) | 6 (1.4) |
Japan | 11 (8.0) | 4 (5.9) | 12 (8.5) | 6 (8.6) | 10 (7.2) | 33 (7.9) |
Australia/New Zealand | 34 (24.8) | 17 (25.0) | 35 (24.8) | 17 (24.3) | 34 (24.6) | 103 (24.8) |
Ethnicity | ||||||
White | 115 (83.9) | 60 (88.2) | 124 (87.9) | 64 (91.4) | 124 (89.9) | 363 (87.3) |
Black | 2 (1.5) | 1 (1.5) | 1 (0.7) | 0 | 1 (0.7) | 4 (1.0) |
Asian | 12 (8.8) | 4 (5.9) | 12 (8.5) | 6 (8.6) | 10 (7.2) | 34 (8.2) |
American Indian | 0 | 0 | 1 (0.7) | 0 | 0 | 1 (0.2) |
Native Hawaiian | 5 (3.6) | 1 (1.5) | 2 (1.4) | 0 | 1 (0.7) | 8 (1.9) |
Not reported | 3 (2.2) | 2 (2.9) | 1 (0.7) | 0 | 2 (1.4) | 6 (1.4) |
FEV1 % pred | 59.42±16.7 | 57.37±15.5 | 59.48±15.1 | 61.7±16.7 | NC | 59.50±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 score | 52.51±21.48 | 58.72±20.40 | 60.72±19.47 | 55.52±22.07 | NC | 56.84±20.95 |
QOL-B RSS | 57.69±18.72 | 50.67±19.59 | 53.01±18.71 | 55.82±18.04 | NC | 54.57±18.87 |
Exacerbations in prior 12 months | 3.0±1.5 | 2.8±1.1 | 2.9±1.3 | 2.9±1.3 | 2.8±1.2 | 2.9±1.4 |
Three or more exacerbations in prior 12 months | 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 macrolides | 24 (17.5) | 8 (11.8) | 22 (15.6) | 12 (17.1) | 20 (14.5) | 66 (15.9) |
History of COPD | 23 (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.