Bone metabolism in children with asthma treated with nebulized flunisolide: A multicenter Italian study

This multicenter, parallel-group, open-label, randomized study was conducte d in prepubertal children with mild asthma to investigate the efficacy and influence on bone and collagen turnover of a daily regimen of flunisolide 1 200 mu g alone (group A, n = 14), flunisolide 600 mu g in combination with sodium cromoglycate (SCG) 60 mg (group B, n = 15), or SCG 60 mg alone (grou p C, n = 15) for 4 months, All medications were administered by means of a jet nebulizer using a mouthpiece. Serum osteocalcin (OC), bone alkaline pho sphate (B-ALP), and procollagen type I carboxyterminal propeptide (PICP) we re measured as markers of bone formation, and type I collagen telopeptide ( ICTP) was measured as a marker of bone resorption before and after treatmen t. The efficacy of the treatment schedules was assessed measuring forced ex piratory volume in 1 second (FEV,) and the use of rescue medication. No sig nificant differences were found in the concentration of OC, B-ALP, PICP, or ICTP between the three treatment groups before the treatment period. In ad dition, no significant changes were found after the treatment period, altho ugh a wide variation in individual response was observed in all markers. In the group treated with flunisolide 1200 mu g/d, FEV1 improved significantl y after treatment; no significant improvement in FEV, was observed in the o ther two groups. The number of children who needed rescue medication was re duced to 14.3% in group A, 20.0% in group B, and 53.3% in group C, The resu lts of the present study suggest that a 4-month regimen of nebulized flunis olide 1200 mu g/d is effective in patients with mild asthma and does not al ter bone or collagen turnover markers. However, the differences in individu al response to therapy make it necessary to examine further the issues of b one metabolism in flunisolide-treated children with asthma.