Once-Daily vs. Twice-Daily Administration of Inhaled Budesonide for Mild and Moderate Well-Controlled Childhood...

Area of Science:

• Pediatric Pulmonology
• Pharmacology
• Clinical Trials

Background:

• Asthma management in children often involves inhaled corticosteroids like budesonide.
• Dosing frequency of inhaled budesonide can impact adherence and efficacy.
• Optimizing budesonide administration is crucial for effective asthma control in pediatric patients.

Purpose of the Study:

• To compare the efficacy of once-daily versus twice-daily inhaled budesonide in children with mild to moderate asthma.
• To assess the impact of different budesonide dosing regimens on lung function and clinical asthma control.

Main Methods:

• A randomized, parallel-group, open-label, noninferiority trial involving 80 children aged 5-12 years.
• Participants received a total daily dose of inhaled budesonide administered either once-daily or divided into twice-daily doses.
• Primary outcome was the median change in morning peak expiratory flow rate (PEFR); secondary outcomes included PEFR variations, asthma symptom control (Global Initiative for Asthma, Asthma Control Questionnaire), and spirometry.

Main Results:

• No statistically significant difference was observed in the median change of morning PEFR between once-daily and twice-daily budesonide groups (p=0.222).
• While most secondary outcomes, including spirometric measures and symptom scores, were non-significant, a trend favored the twice-daily regimen for evening PEFR.
• The study met its noninferiority objective for the primary outcome.

Conclusions:

• Once-daily administration of inhaled budesonide is noninferior to twice-daily administration of an equivalent total daily dose in children with mild to moderate asthma.
• The findings suggest that once-daily dosing is a viable and effective option for budesonide therapy in this population.
• Further research may explore patient-reported outcomes and long-term adherence differences between the two regimens.