Baseline patient demographic and clinical characteristics (intention-to-treat group)
| CDPI (n=183) | TIS (n=191) | Total (n=374) | |
|---|---|---|---|
| Mean age (SD), years | 21.3 (9.72) | 20.9 (9.30) | 21.1 (9.49) |
| Range | 6–55 | 6–56 | 6–56 |
| Male (%) | 103 (56.3) | 101 (52.9) | 204 (54.5) |
| Female (%) | 80 (43.7) | 90 (47.1) | 170 (45.5) |
| Mean weight (SD), kg | 49.37 (15.501) | 48.69 (15.779) | 49.02 (15.626) |
| 6–12 years | 24.35 (6.096) | 28.42 (10.907) | 26.53 (9.174) |
| 13–17 years | 44.63 (9.194) | 41.33 (8.990) | 42.89 (9.185) |
| 18+ years | Not available | Not available | Not available |
| Mean BMI (SD), kg/m2 | 18.67 (3.396) | 18.46 (3.584) | 18.56 (3.490) |
| 6–12 years | 14.42 (1.786) | 14.99 (3.814) | 14.73 (3.041) |
| 13–17 years | 17.42 (2.576) | 16.80 (2.465) | 17.09 (2.522) |
| 18+ years | Not available | Not available | Not available |
| Percentage of patients with FEV1% predicted <50% | 44.8 | 49.7 | 47.3 (no difference, p=0.375) |
| Mean FEV1% predicted (SD) | 49.14 (14.895) | 50.80 (6.336) | 49.78 (11.980) |
| 6–12 years | 54.15 (15.637) | 52.14 (14.305) | 53.07 (14.855) |
| 13–17 years | 51.26 (15.115) | 52.69 (14.696) | 52.02 (14.825) |
| 18+ years | |||
| Mean time since diagnosis (SD), years | 17.1 (8.77) | 17.5 (8.71) | 17.3 (8.73) |
BMI, body mass index; CDPI, Colobreathe dry powder for inhalation; FEV1, forced expiratory volume in 1 s; TIS, tobramycin inhaler solution.