caa a22 4500 475818350 CHVBK 20180406123815.0 cr unu---uuuuu 170329e20000601xx s 000 0 eng 10.1007/s002280000134 doi (NATIONALLICENCE)springer-10.1007/s002280000134 A randomized controlled assessment of the systemic activity of budesonide when given once or twice daily via Turbuhaler [Elektronische Daten] [L. Thorsson, A. Källén] Objective: To compare the effects on the hypothalamo-pituitary-adrenal (HPA) axis of budesonide, delivered via Turbuhaler at doses of 800 μg once daily in the morning or evening or 400 μg twice daily. Methods: Healthy men (n=24) received four treatments in random order: budesonide, 800 μg in the morning and placebo in the evening; budesonide, 800 μg in the evening and placebo in the morning; budesonide, 400 μg in the morning and evening; placebo in the morning and evening. Each treatment was given for 1 week, with a 2-week washout period between treatments. Blood samples for measurement of plasma cortisol were obtained before the evening dose on day 6 of each treatment period and over the following 22 h. Results: All three budesonide regimens produced a statistically significant reduction (mean 16-19%) in the area under the curve of plasma cortisol concentration versus time over 22 h (AUC0-22h) compared with placebo. There were no statistically significant differences among the three regimens. These reductions in plasma cortisol concentrations were not considered to be clinically significant. Analysis of the fractional AUCs measured 0-10 h and 10-22 h after dosing showed that evening dosing had a greater effect on nocturnal cortisol than morning dosing; daytime cortisol was reduced by all treatments. Conclusion: There was no significant difference between the effects on plasma cortisol of budesonide 400 μg twice daily and 800 μg once daily in the morning or evening. Springer-Verlag Berlin Heidelberg, 2000 Key words Budesonide nationallicence Cortisol nationallicence Inhaled corticosteroids nationallicence Thorsson L. Experimental Medicine, AstraZeneca R&D Lund, S-22187 Lund, Sweden e-mail: Lars.Thorsson@astrazeneca.com Tel.: +46-46-336337; Fax: +46-46-337192, SE aut Källén A. Experimental Medicine, AstraZeneca R&D Lund, S-22187 Lund, Sweden e-mail: Lars.Thorsson@astrazeneca.com Tel.: +46-46-336337; Fax: +46-46-337192, SE aut https://doi.org/10.1007/s002280000134 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s002280000134 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Thorsson L. Experimental Medicine, AstraZeneca R&D Lund, S-22187 Lund, Sweden e-mail: Lars.Thorsson@astrazeneca.com Tel.: +46-46-336337; Fax: +46-46-337192, SE aut NATIONALLICENCE 700 1- Källén A. Experimental Medicine, AstraZeneca R&D Lund, S-22187 Lund, Sweden e-mail: Lars.Thorsson@astrazeneca.com Tel.: +46-46-336337; Fax: +46-46-337192, SE aut Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer