Inhalatietherapie met cromoglycaat bij jonge kinderen met matig ernstig astma : Een gerandomiseerde placebogecontroleerde trial

Background: Inhalation therapy with sodium cromoglycate is recommended as first step prophylactic treatment in moderate asthma in children. The availability of spacer devices with face mask has extended the applicability of metered dose inhalers to children of preschool age. We studied the feasibility and effects of this therapy compared to placebo in children aged 1 to 4 years. Methods: Children 1 to 4 years of age, with moderate asthma (n=218) were recruited through 151 general practitioners and were prescribed sodium cromoglycate (10 mg three times per day) or placebo, given by spacer device with face-mask (Aerochamber7), randomised and double blind, for 5 months. Rescue medication was available during the baseline period of 1 month and the intervention period. Parents completed a daily symptom-score list. Primary outcome measure was the proportion of symptom-free days in month 2 to 5. Analysis was both by intention to treat and on treatment. Results: 167 (77 per cent) of all children completed the trial, 131 (78 per cent) of them used at least 80 per cent of the recommended dose. Of the 51 children who stopped prematurely, 23 had feasibility problems. The mean proportion of symptom-free days for both groups was greater for the treatment period than for the baseline period (95% CI for mean difference 5.1 to 17.5 cromoglycate, 11.9 to 23.3 placebo). However there were no differences between the sodium cromoglycate and placebo groups in the proportion of symptom-free days (mean 65.7 [SD 25.3] vs 64.3 [24.5] per cent; 95% CI for difference -8.46 to 5.70) or in any other outcome measure. Conclusions: Our study in a general practice setting shows that inhalation therapy with a spacer device and face-mask is feasible in a majority of children below the age of four. However, long- term prophylactic therapy with inhaled sodium cromoglycate is not more effective than placebo in this age-group.