Safety of Mometasone Furoate Nasal Spray in Children with Allergic Rhinitis as Young as 2 Years of Age: A Randomized Controlled Trial

Current treatment guidelines recommend intranasal corticosteroids or nonsedating antihistamines as first-line therapy for allergic rhinitis (AR). Because of concerns regarding the systemic safety of intranasal corticosteroids in children, the present study was conducted to evaluate systemic activity of mometasone furoate nasal spray (MFNS) in children as young as 2 years of age with AR. This was a randomized, third-party blind, parallel-group, placebo-controlled trial conducted at a single research center with 56 subjects from 2 to <6 years of age. Subjects were randomized to 100 µg MFNS or placebo once daily in the morning (one 50 µg spray/nostril) for 42 consecutive days. The primary variables were serum cortisol concentration and 24-hour urinary free cortisol, corrected for creatinine (UFC) at end of treatment. Baseline values for serum cortisol (AUC(0–24)) were comparable for MFNS and placebo (225.2 µg/hour/dL and 232.3 µg/hour/dL, respectively), as were baseline values for UFC (75.8 µg/gm per 24 hours, and 76.0 µg/gm per 24 hours, respectively). At end point, serum cortisol (AUC(0–24)) values were 216.7 µg/hour/dL in the MFNS group and 201.1 µg/hour/dL in the placebo group. The UFC values at end point were 51.6 µg/gm 24 hours and 98.4 µg/gm 24 hours in the MFNS and placebo groups, respectively. No significant differences were observed between treatments, and neither treatment was associated with significant changes from baseline in serum cortisol or urinary free cortisol. This study demonstrates that treatment with MFNS 100 µg once daily in the morning in patients as young as 2 years of age had negligible systemic exposure and did not appear to affect hypothalamic-pituitary-adrenal (HPA) axis function. (Pediatr Asthma Allergy Immunol 2006; 19[3]:146–153.