Bone metabolism in children with asthma treated with nebulized flunisolide: a multicenter italian study

Abstract

This multicenter, parallel-group, open-label, randomized study was conducted in prepubertal children with mild asthma to investigate the efficacy and influence on bone and collagen turnover of a daily regimen of flunisolide 1200 μg alone (group A, n = 14), flunisolide 600 μg in combination with sodium cromoglycate (SCG) 60 mg (group B, n = 15), or SCG 60 mg alone (group C, n = 15) for 4 months. All medications were administered by means of a jet nebulizer using a mouthpiece. Serum osteocalcin (OC), bone alkaline phosphate (B-ALP), and procollagen type I carboxyterminal propeptide (PICP) were measured as markers of bone formation, and type I collagen telopeptide (ICTP) was measured as a marker of bone resorption before and after treatment. The efficacy of the treatment schedules was assessed measuring forced expiratory volume in 1 second (FEV 1) and the use of rescue medication. No significant differences were found in the concentration of OC, B-ALP, PICP, or ICTP between the three treatment groups before the treatment period. In addition, no significant changes were found after the treatment period, although a wide variation in individual response was observed in all markers. In the group treated with flunisolide 1200 μg/d, FEV 1 improved significantly after treatment; no significant improvement in FEV 1, was observed in the other two groups. The number of children who needed rescue medication was reduced to 14.3% in group A, 20.0% in group B, and 53.3% in group C. The results of the present study suggest that a 4-month regimen of nebulized flunisolide 1200 μg/d is effective in patients with mild asthma and does not alter bone or collagen turnover markers. However, the differences in individual response to therapy make it necessary to examine further the issues of bone metabolism in flunisolide-treated children with asthma.