Asthma Control in Young Children Treated with Once-Daily Budesonide Turbuhaler®Who Were Previously Treated with Budesonide Inhalation Suspension

Abstract

Budesonide inhalation suspension (Pulmicort Respules®), administered through jet nebulization, and budesonide dry powder inhaler (Pulmicort Turbuhaler®) are used for the treatment of asthma; however, the age indication for these products varies by country. In the United States, the indication for budesonide inhalation suspension is limited to children aged 12 months to 8 years. In many countries, budesonide Turbuhaler is indicated for use in children as young as 5 years. This clinical study assessed asthma control in children aged 4–6 years when transitioning from budesonide inhalation suspension to budesonide Turbuhaler. Ten children maintained on once-daily budesonide inhalation suspension (0.25 or 0.5 mg) were transitioned to once-daily budesonide Turbuhaler (200 μg) for 6 weeks after a 2-week run-in period, during which the original dose of budesonide inhalation suspension was continued. The primary outcome assessment was the change from baseline to the average during the last 2 weeks of treatment in morning and evening peak expiratory flow (PEF) measurements. Secondary outcomes were short-acting β2-adrenergic agonist (SABA) use, asthma symptom scores, and adverse events; peak inspiratory flow (PIF) also was assessed. Patients were able to maintain asthma control when transitioned from budesonide inhalation suspension to budesonide Turbuhaler. Mean improvements from baseline in morning and evening PEF were 19.1 and 16.8 L/min, respectively. At study end, no differences were observed in SABA use or daytime and nighttime asthma symptom scores compared with baseline. All but one patient demonstrated PIF values ≥30 L/min at all visits throughout the study. No unexpected adverse events were observed, and no patients discontinued from the study. These results suggest that children with asthma aged 4–6 years can successfully be transitioned from once-daily budesonide inhalation suspension to budesonide Turbuhaler while maintaining asthma control.