Safety, tolerability, and exposure of ciclesonide nasal spray in healthy and asymptomatic subjects with seasonal allergic rhinitis.

Ciclesonide is an intranasal corticosteroid in development for the treatment of allergic rhinitis. To assess the safety, tolerability, and pharmacokinetics of ciclesonide, adult healthy volunteers and asymptomatic subjects with seasonal allergic rhinitis were randomized to receive intranasal ciclesonide or placebo for 14 days. Serum concentrations of ciclesonide and its active metabolite, desisobutyryl-ciclesonide, were measured using high-performance liquid chromatography assay with tandem mass spectrometric detection, with lower limits of quantification of 25 and 10 pg/mL, respectively.