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

BACKGROUND

Recurrent wheezing illness in childhood is a frequent reason for consultation in both primary and secondary care and whilst there is widespread 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 introduction of ICS.

METHODS

We entered 86 children (mean age 4.5 years) with at least two consecutive wheezing episodes into a pragmatic randomized controlled trial. All children were already being prescribed beta2-agonist and those allocated to ICS were prescribed twice daily beclomethasone dipropionate 200 microg or budesonide 200 microg. At entry and 3 and 6 months age appropriate lung function (FEV(1), T(ptef):T(e)), respiratory symptoms, quality of life of children and carers, growth and sexual maturation, bone mass and bone turnover, and health care costs were assessed.

RESULTS

Drop out rate was 8% (7 of 86). No significant differences were found in FEV(1) or T(ptef):T(e) at 6 months. Respiratory symptoms and health-related 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 the 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 practical and acceptable. In order to confirm these results, and using the same study design, power estimates indicated that 260 children would need to be randomized.