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Table 1 PK parameters after multiple dosing of tiotropium delivered by the Respimat® inhaler in children aged 6–11 years with moderate asthma

From: 5th Pediatric Allergy and Asthma Meeting (PAAM)

Parameter Unit Tiotropium Respimat 2.5 µg Tiotropium Respimat 5 µg
N gMean gCV [%] N gMean gCV [%]
AUC0–1,ss pg h/mL 3 2.08 31.7 5 3.04 38.3
Cmax,ss pg/mL 6 2.42 48.7 5 4.10 97.2
Cpre,ss pg/mL     3 1.82 13.4
tmax,ss* min 6 4.1* 3.2–5.0* 5 4.7* 3.5–5.8*
CLR0–3,ss mL/min 3 358 7.06 4 278 17.9
RA, Ae0–24   11 3.43 115 12 1.71 126
fe0–3,ss % 11 2.88 48.3 12 2.02 65.2
fe0–24,ss % 11 10.3 62.7 12 7.39 86.3
  1. *Median, minimum–maximum. Ae0–24 = amount of tiotropium that was eliminated unchanged in urine from 0 to 24 h; AUC0–1,ss = area under the curve from 0 to 1 h at steady state; Cmax,ss = maximum measured concentration of the analyte in plasma at steady state; Cpre,ss = pre-dose steady state concentration of the analyte in plasma immediately before administration of the next drug administration; CLR,0–3,ss = renal clearance of tiotropium in plasma from 0 to 3 h at steady state; fe0–3 ss = fraction of tiotropium dose excreted in urine from 0 to 3 h at steady state; fe0–24,ss = fraction of tiotropium dose excreted in urine from 0 to 24 h post-dose at steady state; gCV = geometric coefficient of variation; gMean = geometric mean; RA,0–24 = accumulation ratio from 0 to 24 h; tmax,ss = time from dosing to maximum tiotropium plasma concentration at steady state