Early introduction of inhaled steroids in wheezing children presenting in primary care. A pilot study

Background Recurrent wheezing illness in childhood is a frequent reason for consultation in both primary and secondary carl and whilst there is widesp read support for the earlier introduction of inhaled corticosteroids (ICS) concerns remain about potential adverse systemic effects. Objective We sought to identify the feasibility and size of study required to assess the benefits, adverse effects and cost-effectiveness of early int roduction of ICS. Methods We entered 86 children (mean age 4.5years) with at least two consec utive wheezing episodes into a pragmatic randomized controlled trial. All c hildren were already being prescribed beta (2)-agonist and those allocated to ICS were prescribed twice daily beclomethasone dipropionate 200 mug or b udesonide 200 mug. At entry and 3 and 6 months age appropriate lung functio n (FFV1, T-ptef:T-e), respiratory symptoms, quality of life of children and carers, growth and sexual maturation, bone mass and bone turnover, and hea lth care costs were assessed. Results Drop out rate was 8% (7 of 86). No significant differences were fou nd in FEV1 or T-ptef:T-e at 6 months. Respiratory symptoms and health-relat ed quality of life of children and carers improved equally in both groups. No significant differences were found in growth rates or in bone mass. In t he ICS group markers of bone turnover (Pyd:Cr) fell (271 vs 237 nmol/mmol) in contrast to a rise in those on beta (2) alone (255 vs 319 nmol/mmol) P < 0.05. Combined health care costs were higher in the ICS group, Conclusions The low drop out rate provided evidence that the protocol was p ractical and acceptable. In order to confirm these results, and using the s ame study design, power estimates indicated that 260 children would need to be randomized.