Safety of Once-Daily Ciclesonide Nasal Spray in Children 2 to 5 Years of Age with Perennial Allergic Rhinitis

Abstract

Two double-blind studies in children aged 2 to 5 years with perennial allergic rhinitis (PAR) assessed the safety and efficacy of the intranasal corticosteroid ciclesonide. In the first study, 133 patients were randomized to once-daily ciclesonide 25, 100, or 200 μg or placebo for 6 weeks. In the second study, 125 patients were randomized to once-daily ciclesonide 200 μg or placebo for 12 weeks. Safety evaluations included adverse events, nasal examinations, and cortisol levels. Serum concentrations of ciclesonide and its pharmacologically active metabolite, desisobutyryl-ciclesonide (des-CIC), were measured at the end of the 6-week study. Efficacy evaluations included patient/caregiver-assessed 24-hour reflective total nasal symptom scores (TNSS), and physician-assessed nasal symptom scores (PNSS). Ciclesonide was well tolerated, demonstrating a safety profile comparable with placebo. Changes in plasma or urine cortisol levels in patients receiving ciclesonide ≤200 μg/day were not significantly different from placebo or indicative of a treatment-related effect. Systemic exposure to ciclesonide was low. Using a sensitive assay, serum concentrations of ciclesonide and des-CIC were below the lower limit of quantification in many samples. The highest detectable value of des-CIC was 64.5 pg/mL, observed in a patient receiving ciclesonide 25 μg. Although primarily designed to assess safety, both studies displayed evidence of efficacy. In the 12-week study, ciclesonide demonstrated significantly greater reductions in TNSS compared with placebo over the entire treatment period. Intranasal ciclesonide ≤200 μg/day appears to have a favorable safety profile and reduces nasal symptoms in children aged 2 to 5 years with PAR.