TABLE 2.
Plasma PK parameters, and comparison between the two groups
| Parameter | Adolescent (N = 40) | Adult (N = 40) | Adolescent versus adult adjusted point estimate (90% CI) |
|---|---|---|---|
| B17MP | |||
| C max (pg/ml) | 831 (328) | 1046 (455)a | 81.07 (68.58; 95.84) |
| t max (h) | 0.50 (0.08; 2.00) | 0.50 (0.08; 2.02)a | 0.00 (−0.02; 0.23) |
| AUC0–30min (h·pg/ml) | 307 (134) | 381 (205)a | 86.74 (69.88; 107.67) |
| AUC0–t (h·pg/ml) | 3204 (909) | 4027 (1022)a | 79.28 (71.19; 88.29) |
| AUC0–∞ (h·pg/ml) | 3660 (1058)b | 4764 (1282)c | 76.65 (67.40; 87.16) |
| t ½ (h) | 3.47 (0.633)d | 4.00 (1.11)a | 88.47 (81.22; 96.36) |
| Formoterol | |||
| C max (pg/ml) | 20.9 (8.27)b | 27.2 (12.0)e | 78.83 (65.76; 94.49) |
| t max (h) | 0.08 (0.08; 4.00)b | 0.08 (0.08; 2.02)e | 0.00 (0.00; 0.00) |
| AUC0–30min (h·pg/ml) | 7.12 (2.95)b | 9.75 (4.59)e | 77.87 (62.38; 97.20) |
| AUC0–t (h·pg/ml) | 73.8 (21.8)f | 84.6 (26.6)e | 88.68 (77.71; 101.20) |
| AUC0–∞ (h·pg/ml) | 93.0 (26.5)g | 92.8 (36.5)h | 103.95 (82.52; 130.94) |
| t ½ (h) | 4.46 (1.20)i | 5.25 (1.43)k | 85.27 (77.04; 94.38) |
| Glycopyrronium bromide | |||
| C max (pg/ml) | 25.6 (15.2) | 39.5 (31.7)a | 76.00 (59.92; 96.39) |
| t max (h) | 0.08 (0.08; 2.00) | 0.08 (0.08; 2.02)a | 0.00 (0.00; 0.00) |
| AUC0–30min (h·pg/ml) | 8.81 (5.21) | 13.3 (9.60)a | 74.25 (58.44; 94.35) |
| AUC0–t (h·pg/ml) | 74.5 (27.5) | 90.1 (39.1)a | 85.49 (72.96; 100.16) |
| AUC0–∞ (h·pg/ml) | 91.7 (31.4)l | 102 (47.7)m | 93.15 (77.88; 111.42) |
| t ½ (h) | 4.20 (1.66)a | 4.75 (1.91)e | 90.04 (79.31; 102.23) |
| Beclometasone dipropionate | |||
| C max (pg/ml) | 607 (623) | 1724 (1508) | 31.56 (22.32; 44.63) |
| t max (h) | 0.08 (0.08; 0.25) | 0.08 (0.08; 0.27) | 0.00 (0.00; 0.00) |
| AUC0–t (h·pg/ml) | 111 (118) | 282 (235) | 35.35 (24.42; 51.17) |
Note: Adolescent and adult data are arithmetic mean (SD), except t max, which is median (range). The adolescent versus adult point estimate data are ratios of adjusted geometric means of log‐transformed parameters from the linear model except t max, which is the Hodges‐Lehmann non‐parametric estimate of location shifts based on untransformed data. n = a38, b36, c24, d39, e37, f34, g17, h9, i32, k33, l27, m20. B17MP, beclometasone 17‐monopropionate; C max, maximum plasma concentration; t max, time to maximum plasma concentration; AUC, area under the curve from 0 to 30 min (0–30 min), 0 to the last quantifiable concentration (0–t), and extrapolated to infinity (0–∞); t ½ plasma elimination half‐life.