Once-Daily vs. Twice-Daily Administration of Inhaled Budesonide for Mild and Moderate Well-Controlled Childhood Asthma: A Randomized, Controlled Trial

Objectives: To compare median change in morning peak expiratory flow rate (PEFR) and clinical asthma control in children receiving total daily dosage of inhaled budesonide administered either as once-daily or divided twice-daily dose.

Methods: It was a randomized, parallel group, open label, noninferiority trial on 80 children aged 5-12 y with mild or moderate well-controlled asthma. Baseline parameters were recorded and subjects received inhaled budesonide either as once-daily or divided twice-daily dose. Primary outcome was median change in morning PEFR. Secondary outcomes included median change in evening and diurnal variation in PEFR, asthma symptom control as per Global Initiative for Asthma, 2017 and Asthma Control Questionnaire, and spirometric measurements taken at the clinic.

Results: The median [interquartile range (IQR)] increase in morning PEFR was more in children receiving once-daily as compared to those receiving twice-daily inhaled budesonide (by 6:00 L/min; IQR: -44.00-63.00 L/min vs. 4:00 L/min; IQR: -67.50-67.50 L/min, p 0.222; 95% CI: -1.37 to 19.08). Other spirometric variables and symptoms scores were also nonsignificant except median change in evening PEFR which was in favor of twice-daily regimen.

Conclusion: Once-daily administration of inhaled budesonide is noninferior to twice-daily administration of equivalent daily dosage of inhaled budesonide.