Budesonide Inhalation Suspension Versus Montelukast in Children Aged 2 to 4 Years with Mild Persistent Asthma

Background Budesonide inhalation suspension (BIS) and montelukast provide acceptable asthma control, whereas overall measures favored BIS in children aged 2 to 8 years with mild persistent asthma. Objective We compared BIS and montelukast over a 1-year period in children aged 2 to 4 years with asthma. Methods Data were derived from a 52-week, open-label, randomized, active-controlled, multicenter study (NCT00641472). Children with mild asthma received either BIS 0.5 mg or montelukast 4 to 5 mg once daily. Patients were stepped up to twice-daily BIS or oral corticosteroids for mild or severe asthma worsening, respectively. Primary efficacy assessment was time to first additional asthma medication for exacerbation over 52 weeks. Results Two hundred two patients, age 2 to 4 years, received BIS (n = 105) or montelukast (n = 97). No difference was observed between the BIS and montelukast groups in median time to first additional asthma medication over 52 weeks (183 vs 86 days). Statistically significant differences were observed in favor of BIS over montelukast in the percentage of patients requiring oral steroids at 52 weeks (21.9% vs 37.1%; P  = .022), the rate (number/patient/year) of additional courses of medication (1.35 vs 2.30; P  = .003), the rate of additional oral steroid therapy (0.44 vs 0.88; P  = .008), and caregivers' ability to manage the patient's symptoms ( P  = .026). Both treatments were well tolerated. Conclusion BIS and montelukast provided acceptable asthma control in children aged 2 to 4 years with mild persistent asthma with no significant difference between treatments in the primary end point; however, several secondary outcomes showed statistically significant differences (and many had numerical differences) in favor of BIS over montelukast.