2010 Volume 24 Issue 5 Pages 753-762
Children with bronchial asthma sometimes retain nocturnal symptoms of asthma despite treatment with medications for intermittent or mild persistent asthma, other than inhaled corticosteroids and inhaled disodium cromoglycate (DSCG). To evaluate the effects of add-on therapy with budesonide inhalation suspension (BIS) on nocturnal sleep disturbance and caregivers' quality of life (QOL) as compared to DSCG, we conducted a multicenter, open-label, randomized, parallel-group comparative study of such children aged 6 months to <5 years. Of 34 children enrolled, 7 were ineligible for reasons including the absence of nocturnal sleep disturbance during the last week of the observation period. The remaining 27 were randomized and 26 of them were included in the analysis. After 4 weeks of treatment, BIS produced a significantly greater improvement than DSCG in the nocturnal sleep disturbance score, the primary endpoint of the study, as well as in the asthma symptom score. Caregivers of children treated with BIS also experienced substantial improvements in QOL. There was a good correlation between the nocturnal sleep disturbance scores and caregivers' QOL scores. These results indicate that add-on therapy with BIS improves nocturnal sleep disturbance in children who remain symptomatic despite treatment and thereby also improves QOL of their caregivers.
