Demographic information of cystic fibrosis subjects enrolled in the open-label extension study evaluating repeated cycles of once daily 560 mg Arikace (mean (SD)—all from European sites)
| Arikace 560 mg (n=33) | Placebo (n=16) | Total (n=49) | |
|---|---|---|---|
| Age (yr) | 17.7 (6.1) | 16.7 (6.7) | 17.4 (6.2) |
| Females, n (%) | 21 (63.6) | 8 (50.0) | 29 (59.2) |
| FEV1 (L) | 1.89 (0.77) | 1.84 (0.80) | 1.87 (0.772) |
| FEV1 (% predicted) | 59.5 (19.7) | 58.5 (19.00) | 59.2 (19.3) |
| FEF25–75% (L/sec) | 1.33 (0.72) | 1.35 (0.88) | 1.34 (0.766) |
| FVC (L) | 2.71 (1.12) | 2.66 (1.12) | 2.69 (1.109) |
| BMI (kg/m2) | 18.65 (3.25) | 17.95 (2.85) | 18.43 (3.11) |
Subjects are segregated by their original treatment assignment during the randomised, double-blind placebo controlled trial that preceded the open-label trial.
BMI, body mass index; FVC, forced vital capacity; FEF, forced expiratory flow.