TABLE 1.
Baseline demographic and clinical characteristics (all treated patients)
| Tobramycin inhalation powder (n = 46) | Placebo (n = 49) | |
|---|---|---|
| Age (years), mean (SD) | 13.4 (4.42) | 13.2 (3.91) |
| Age group, n (%) | ||
| ≥6 to <13 years | 21 (45.7) | 24 (49.0) |
| ≥13 to <22 years | 25 (54.3) | 25 (51.0) |
| Sex, n (%) | ||
| Females | 27 (58.7) | 26 (53.1) |
| Males | 19 (41.3) | 23 (46.9) |
| Race, n (%) | ||
| Black | 0 (0) | 1 (2.0) |
| Caucasian | 37 (80.4) | 43 (87.8) |
| Hispanic | 8 (17.4) | 4 (8.2) |
| Other | 1 (2.2) | 1 (2.0) |
| Body mass index (kg/m2), mean (SD) | 16.8 (3.6) | 17.1 (3.1) |
| FEV1 % predicted,* mean (SD) | 54.7 (18.89) | 58.5 (20.03) |
| FEV1 % predicted distribution*, n (%) | ||
| <25 | 1 (3.1) | 3 (8.1) |
| ≥25–<50 | 13 (40.6) | 11 (29.7) |
| ≥50–≤80 | 16 (50.0) | 18 (48.6) |
| >80 | 2 (6.3) | 5 (13.5) |
*
Excluding patients from Latin American sites with any potential spirometry quality concerns (TIP n = 32 and placebo n = 37); SD = standard deviation; FEV1 = forced expiratory volume in one second