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Title: Efficacy and Safety of Ciclesonide Nasal Spray in Children With PAR: Presented at AAFP

"Efficacy and Safety of Ciclesonide Nasal Spray in Children With PAR: Presented at AAFP"

By Laura Gater CHICAGO, IL -- October 9, 2007 -- Ciclesonide nasal spray was well tolerated and had a safety profile comparable with placebo in the treatment of children with perennial allergic rhinitis (PAR), according to William E. Berger, MD, Allergy & Asthma Associates of Southern California, Mission Viejo, CA, at the American Academy of Family Physicians (AAFP) Scientific Assembly here on October 5. Intranasal corticosteroids (INCs) are the standard of care for PAR. The objective of the study by Dr. Berger and his colleagues was to evaluate the efficacy and safety of ciclesonide nasal spray in the treatment of children with PAR. In this phase 3, randomized, double-blind, placebo-controlled, parallel-group study, 665 children (aged 6 to 11 years) with a history of PAR for at least 6 months received ciclesonide nasal spray 25, 100, or 200 mcg, or placebo once daily for 12 weeks. Efficacy endpoints included the average morning (AM) and evening (PM) patient-/caregiver-reported reflective total nasal symptom score (TNSS) and an overall physician assessment of nasal symptom severity (PANS). There were trends of effectiveness observed between ciclesonide 200 mcg and placebo over the first 6 weeks of treatment in both TNSS and PANS (treatment difference, 0.80; 95% CI = 0.2, 1.4; [P =.006 vs placebo). These effects were not observed with lower doses of ciclesonide.

The adverse event profile was similar in ciclesonide- and placebo-treated patients. The most commonly reported adverse event was epistaxis, which occurred at the highest incidence in the placebo group. Changes in urine and plasma cortisol and intraocular pressure were small and not indicative of a treatment-related effect.

Emergent adverse events occurred in 4% or more of patients in any treatment group, and only 2 of 162 plasma samples obtained from patients receiving ciclesonide had detectable levels of ciclesonide, noted Dr. Berger.

The study concluded that intranasal ciclesonide 200 mcg once daily resulted in a trend toward an improvement in AM and PM reflective TNSS and PANS in children with PAR. Additionally, ciclesonide was well tolerated and had a safety profile comparable with placebo, with median C_maxlevels <10 pg/mL.

[Presentation title: Efficacy and Safety of Ciclesonide Nasal Spray in Children With Perennial Allergic Rhinitis.]

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