Dose 32.5 mg | Dose 48.75 mg | |||
---|---|---|---|---|
Ciprofloxacin DPI N=93 | Placebo N=65 | Ciprofloxacin DPI N=93 | Placebo N=35 | |
Sex, n (%) | ||||
Male | 44 (47.3) | 39 (60.0) | 51 (54.8) | 19 (54.3) |
Female | 49 (52.7) | 26 (40.0) | 42 (45.2) | 16 (45.7) |
Age, years (mean) | 27.7 | 31.7 | 29.3 | 29.1 |
Weight, kg (mean) | 61.9 | 64.7 | 61.3 | 61.4 |
BMI (mean kg/m2) | 22.3 | 22.8 | 21.7 | 21.6 |
Ethnicity, n (%) | ||||
Caucasian | 90 (96.8) | 65 (100) | 90 (96.8) | 35 (100) |
Black or African American | 3 (3.2) | 0 (0) | 1 (1.1) | 0 (0) |
Asian | 0 (0) | 0 (0) | 1 (1.1) | 0 (0) |
American Indian or Alaskan native | 0 (0) | 0 (0) | 1 (1.1) | 0 (0) |
FEV1% predicted, mean | 55.0 | 54.8 | 54.7 | 52.7 |
Range | 31.0–76.6 | 36.0–74.2 | 33.0–79.0 | 36.0–78.0 |
Q1–Q3 | 47.0–63.0 | 46.0–63.5 | 43.0–65.3 | 45.9–60.0 |
Macrolide use, n (%) | ||||
Yes | 65 (69.9) | 47 (72.3) | 66 (71.0) | 19 (54.3) |
No | 28 (30.1) | 18 (27.7) | 27 (29.0) | 16 (45.7) |
Prior antipseudomonal maintenance therapy,* n (%) | 60 (64.5) | 44 (67.7) | 59 (63.4) | 26 (74.3) |
Mean Pseudomonas aeruginosa colony count, log10CFU/g (SD) | 6.73 (2.16) | 7.08 (2.07) | 6.77 (1.89) | 7.37 (1.67) |
Mean number of exacerbations in previous year | 1.6 | 1.6 | 1.9 | 1.3 |
*Therapy was not allowed in the 30 days prior to study drug initiation.
BMI, body mass index; CFU, colony-forming unit; DPI, dry powder for inhalation; FEV1, forced expiratory volume in 1 s.