Abstract
Two double-blind studies in children aged 6 to 11 years with allergic rhinitis (AR) assessed the efficacy and safety of the intranasal corticosteroid ciclesonide. In the first study, 618 patients with seasonal AR (SAR) were randomized to once-daily ciclesonide 100 μg or 200 μg or placebo for 2 weeks. In the second study, 665 patients with perennial AR (PAR) received once-daily ciclesonide 25 μg, 100 μg, or 200 μg or placebo for 12 weeks. Efficacy evaluations included patient-/caregiver-assessed average morning (am) and evening (pm) 12-hour reflective total nasal symptom scores (TNSS) and physician-assessed nasal symptom scores (PNSS). Safety evaluations included adverse events, nasal examinations, and cortisol levels. Serum concentrations of ciclesonide and its pharmacologically active metabolite, desisobutyryl-ciclesonide, were measured after 6 weeks in patients with PAR. In the SAR study, ciclesonide 200 μg demonstrated significantly greater reductions in TNSS compared with placebo over 2 weeks (treatment difference: 0.39; 95% CI: 0.02, 0.76; p = 0.040). In the PAR study, there was a numerical difference in am and pm reflective TNSS between the ciclesonide 200-μg and placebo groups over 6 weeks. Ciclesonide also improved PNSS in patients with SAR or PAR. Ciclesonide demonstrated a safety profile comparable with placebo. Greater numerical decreases in urine cortisol were observed with ciclesonide compared with placebo; however, differences between treatment groups were not considered clinically relevant. Systemic exposure to ciclesonide was low. These studies demonstrate that ciclesonide ≤200 μg/day reduces nasal symptoms and appears to have a favorable safety profile in children with AR.
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