Study: Nasacort AQ doesn't affect kids' height

March 17, 2008

Data announced at the American Academy of Allergy Asthma & Immunology's annual meeting suggests that triamcinolone acetonide is safe for young children with year-round allergic rhinitis.

Data announced at the American Academy of Allergy Asthma & Immunology's annual meeting suggests that triamcinolone acetonide is safe for young children with year-round allergic rhinitis.

Study investigator Paul Ratner, MD, and colleagues tested the theory that continuous use of intranasal corticosteroids to treat very young children with allergic rhinitis could negatively impact their growth. Over 400 children ages 2 to 5 randomly received either Nasacort AQ (an inhaled corticosteroid, by sanofi-aventis) 110 ug or placebo as one spray per nostril per day over a four-week, multicenter, double-blind treatment period. After four weeks, 353 patients then received the same treatment open-label for six months.

The results showed that the stature-for-age distribution among 2- to 5-year-olds with one intranasal corticosteroid was comparable to the placebo group for the same demographic.The corticosteroid and placebo groups also displayed similar treatment-emergent adverse event profiles, consistent with the profile of children 6 and older. No treatment effect was seen in adjusted mean height increase between the corticosteroid and placebo groups after the four-week double-blind period. The height-for-age percentile distribution of patients remained constant over the six-month open label phase, based on the Centers for Disease Control and Prevention growth standards.

The study is part of a supplemental New Drug Application for Nasacort AQ in children 2 to 5, which the Food and Drug Administration recently accepted for review.