An integrated model for the effect of budesonide on ACTH and cortisol in healthy volunteers.

An integrated model for the effect of budesonide on ACTH and cortisol in healthy volunteers. Research Abstract Details 

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An integrated model for the effect of budesonide on ACTH and cortisol in healthy volunteers. Abstract Text:

Anna ,Anders ,Mats O Karlsson,Anna ,Anders ,Mats O Karlsson,

AIMS: Budesonide, a glucocorticosteroid, is used as a first-line treatment for asthma. The aim of the study was to develop a PK/PD model for the effect of budesonide on ACTH and cortisol. METHODS: The modelling data were generated by conducting a single-blind, randomized, placebo-controlled cross-over study. Ten healthy volunteers inhaled placebo (Placebo Turbohaler) and 1600 microg budesonide (Pulmicort Turbohaler), with a wash-out period of 7 days between treatments. Baseline concentrations of cortisol and ACTH were measured after placebo treatment and concentrations of cortisol, ACTH and budesonide were assessed after budesonide treatment. A one-compartment disposition model was used for budesonide disposition. Based on indirect response models, two types of models, distinguishing between production driven by a sum of cosine functions and production driven by surges, were used in parallel to describe the data. RESULTS: The surge-based approach was the most appropriate, based on goodness-of-fit, objective function values and number of parameters. The surge-based model that integrated both ACTH and cortisol data was chosen as the final model. The estimated half-lives of endogenous ACTH and cortisol were 9 and 113 min, respectively. The budesonide and ACTH concentrations producing 50% of the maximal response (IC(50) and A(50)) were 0.325 microg l(-1) and 4.96 pmol l(-1). CONCLUSIONS: The present PK/PD model of the effect of budesonide on ACTH and cortisol can serve as a tool for further understanding of the hypothalamic-pituitary-adrenal (HPA) axis and be useful in the development of drugs interacting with the axis.

An integrated model for the effect of budesonide on ACTH and cortisol in healthy volunteers. Publishing Authors By Initials

A ,A ,MO Karlsson,A ,A ,MO Karlsson,

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An integrated model for the effect of budesonide on ACTH and cortisol in healthy volunteers. Journal Published:

PUBLICATION TYPE: Randomized Controlled Trial

Journal: British journal of clinical pharmacology

VOLUME: 64

Page Numbers: 125-32

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ISSN: 0306-5251

DAY: 1

MONTH: 03

YEAR: 2007

An integrated model for the effect of budesonide on ACTH and cortisol in healthy volunteers. Information

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LANGUAGE: eng

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AFFILIATION: Quintiles AB, Phase I Services, Uppsala and Division of Pharmacokinetics and Drug Therapy, Department of Pharmaceutical Biosciences, Faculty of Pharmacy, Uppsala University, Uppsala, Sweden. anna.lonnebo@quintiles.com

Country: England

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MEDLINETA: Br J Clin Pharmacol

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