5th Pediatric Allergy and Asthma Meeting (PAAM)

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

Parameter	Unit	Tiotropium Respimat 2.5 µg			Tiotropium Respimat 5 µg
Parameter	Unit	N	gMean	gCV [%]	N	gMean	gCV [%]
AUC_0–1,ss	pg h/mL	3	2.08	31.7	5	3.04	38.3
C_max,ss	pg/mL	6	2.42	48.7	5	4.10	97.2
C_pre,ss	pg/mL				3	1.82	13.4
t_max,ss*	min	6	4.1*	3.2–5.0*	5	4.7*	3.5–5.8*
CL_R0–3,ss	mL/min	3	358	7.06	4	278	17.9
R_A, Ae_0–24		11	3.43	115	12	1.71	126
fe_0–3,ss	%	11	2.88	48.3	12	2.02	65.2
fe_0–24,ss	%	11	10.3	62.7	12	7.39	86.3

*Median, minimum–maximum. Ae_0–24 = amount of tiotropium that was eliminated unchanged in urine from 0 to 24 h; AUC_0–1,ss = area under the curve from 0 to 1 h at steady state; C_max,ss = maximum measured concentration of the analyte in plasma at steady state; C_pre,ss = pre-dose steady state concentration of the analyte in plasma immediately before administration of the next drug administration; CL_R,0–3,ss = renal clearance of tiotropium in plasma from 0 to 3 h at steady state; fe_{0–3 ss} = fraction of tiotropium dose excreted in urine from 0 to 3 h at steady state; fe_0–24,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; R_A,_0–24 = accumulation ratio from 0 to 24 h; t_max,ss = time from dosing to maximum tiotropium plasma concentration at steady state

ISSN: 2045-7022