Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Sanofi-Aventis has announced that the continuous use of intranasal corticosteroid Nasacort AQ nasal spray had no treatment effect on stature-for age distribution among children aged 2-5 years old with year-round allergic rhinitis.
Subscribe to our email newsletter
The study included a four-week, multicenter, double-blind treatment period during which 433 children were randomized to receive either Nasacort AQ 110 micrograms or placebo as one spray per nostril once daily. After four weeks, 353 patients entered into a six-month open label Phase receiving treatment with once-daily Nasacort AQ. Height was measured at visit 1 to establish a baseline, visit 4 after the initial four weeks, and visit 8 when the six-month open label period completed.
After the four-week double-blind period, no treatment effect was seen in adjusted mean height increase plus or minus SE (p=0.4086) between children treated with Nasacort AQ (0.62 plus or minus 0.224 cm; n=217) and those receiving placebo (0.38 plus or minus 0.225 cm; n=216). After the 6-month open label period (Visit 8), the adjusted mean increase in height was 3.62 + 0.693 cm.
Paul Ratner, study investigator, said: “Continuous use of intranasal corticosteroids in the treatment of very young children with allergic rhinitis has in the past raised concerns regarding potential effects on growth. I am encouraged by the results which showed that following six month treatment with Nasacort AQ, the stature-for-age distribution did not appear to shift compared to pretreatment in children aged two-five years who suffer from year-round allergies.”