Nebulised beclomethasone dipro ' pionate suspension
SUMMARY We compared nebulised beclomethasone dipropionate suspension against placebo in 16 children with moderately severe asthma in double blind crossover fashion. Three children withdrew due to deterioration while on placebo. Of the remaining 13, eight were better on beclomethasone and five on placebo. These trends in favour of nebulised beclomethasone were not significant and do not suggest that the suspension is as effective as inhaled powder or aerosol topical steroid formulation. The role of beclomethasone dipropionate in childhood asthma is well established, with proven clinical efficacy when administered by either metered dose inhaler' or powder capsule2 3 form. Neither of these two delivery systems is suitable, however, for treatment of very young children, due to the degree of cooperation and coordination required in their use. It is only fairly recently that a suspension form of beclomethasone, for delivery by nebuliser, has become available, but to date there is only one published clinical trial of its effectiveness in a suitable population of young children.4 We have therefore conducted a randomised double blind crossover study, comparing beclomethasone dipro-pionate suspension against placebo in a group of children with moderately severe asthma aged between 18 months and 6 years. Patients and methods The age limits of 18 months and 6 years were chosen to include those children old enou h to be responsive to treatment with bronchodilator but too young to be able to manage treatment with rotahaler or metered dose aerosol effectively. All the children had an established clinical diagnosis of asthma and all had been considered to be inadequately controlled on regular nebulised sodium cromoglycate with nebulised bronchodilator as required. After an initial two week run in period, during which regular prophylactic treatment was stopped, the patients entered two consecutive two month treatment periods. In each of these they received, through a Pari Inhalierboy nebuliser and face mask, either beclomethasone respirator suspension 150 ug (3 ml) or placebo 3 ml (the commercially available preparation minus the active ingredient) on a double blind, randomised crossover basis, and as the sole form of prophylactic treatment. Throughout the trial the parents were asked to maintain a daily diary record of: (i) symptom score, allocating a score of 0-3 for each of cough, wheeze, and breathlessness for both day and night, giving a worst possible score of 18 for each 24 hours; (ii) morning and evening peak expiratory flow rate if the child was capable, using …