caa a22 4500 475819403 CHVBK 20180406123818.0 cr unu---uuuuu 170329e20001201xx s 000 0 eng 10.1007/s002280000212 doi (NATIONALLICENCE)springer-10.1007/s002280000212 Assessment of the systemic effects of beclomethasone dipropionate inhaled via Easyhaler or via Diskhaler in healthy male volunteers [Elektronische Daten] [K.M. Hämäläinen, A. Malinen, M. Granander, P. Toivanen, M. Silvasti] Abstract.: Objective: The objective of this study was to compare the systemic effects of a moderate dose (800µg/day) with the highest recommended dose (1600µg/day) of beclomethasone dipropionate (BDP) inhaled via either Easyhaler or Diskhaler in 15 healthy adult male volunteers. Methods: This was an open, placebo-controlled, randomised study conducted according to a crossover design and consisting of a 1-week baseline period and five 1-week treatment periods, each separated by a 1-week washout period. Subjects received in randomised order 800µg/day BDP via Easyhaler, 1600µg/day BDP via Easyhaler, placebo via Easyhaler, 800µg/day BDP via Diskhaler and 1600µg/day BDP via Diskhaler. Subjects inhaled BDP twice daily at 0800hours and 2000hours. The last dose of each period was inhaled at the study site. Venous blood samples were drawn prior to and at 2-hour intervals for 20h after the last dose. Serum cortisol area under the curve (AUC0-20) and morning serum cortisol values were determined using radioimmunoassay. Urine for analysis of urine cortisol/creatinine ratios (UCC) was collected over a 12-h period after the last dose of each treatment period. Results: According to serum cortisol values, no systemic effects were detected with BDP 800µg/day inhaled via Easyhaler. The mean (±SD) change in serum cortisol AUC0-20 was +118.3±1391nmol h/l compared with placebo. Mean (SD) changes from placebo in serum cortisol AUC0-20 values after BDP 1600µg/day were -546.3±1004nmol h/l with Easyhaler and -769.3±596nmol h/l with Diskhaler. However, there were no statistically significant differences in systemic bioactivity between the active treatments. Morning serum cortisol levels and UCC ratios were consistent with the serum cortisol AUC0-20 data. Conclusions: In conclusion, BDP 800µg/day inhaled via Easyhaler did not reduce serum cortisol AUC0-20 compared with placebo. Although the decrease in hypothalamic-pituitary-adrenal (HPA) axis function after BDP 1600µg/day was statistically significant compared with placebo, the reduction was small and similar with both devices. Springer-Verlag, 2000 Beclomethasone dipropionate Easyhaler Diskhaler nationallicence Hämäläinen K.M. Easyhaler Project, Orion Corporation, Orion Pharma, P.O. Box 1780, FIN-70701 Kuopio, Finland aut Malinen A. Easyhaler Project, Orion Corporation, Orion Pharma, P.O. Box 1780, FIN-70701 Kuopio, Finland aut Granander M. Department of Medical Product Maintenance and Pharmacokinetics, Orion Pharma, Kuopio, Finland aut Toivanen P. Department of Biostatistics, Orion Pharma, Kuopio, Finland aut Silvasti M. Easyhaler Project, Orion Corporation, Orion Pharma, P.O. Box 1780, FIN-70701 Kuopio, Finland aut European Journal of Clinical Pharmacology Springer-Verlag 56/9-10(2000-12-01), 625-629 0031-6970 56:9-10<625 2000 56 228 https://doi.org/10.1007/s002280000212 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s002280000212 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Hämäläinen K.M. Easyhaler Project, Orion Corporation, Orion Pharma, P.O. Box 1780, FIN-70701 Kuopio, Finland aut NATIONALLICENCE 700 1- Malinen A. Easyhaler Project, Orion Corporation, Orion Pharma, P.O. Box 1780, FIN-70701 Kuopio, Finland aut NATIONALLICENCE 700 1- Granander M. Department of Medical Product Maintenance and Pharmacokinetics, Orion Pharma, Kuopio, Finland aut NATIONALLICENCE 700 1- Toivanen P. Department of Biostatistics, Orion Pharma, Kuopio, Finland aut NATIONALLICENCE 700 1- Silvasti M. Easyhaler Project, Orion Corporation, Orion Pharma, P.O. Box 1780, FIN-70701 Kuopio, Finland aut NATIONALLICENCE 773 0- European Journal of Clinical Pharmacology Springer-Verlag 56/9-10(2000-12-01), 625-629 0031-6970 56:9-10<625 2000 56 228 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer