Efficacy and Safety of Pidotimod in Persistent Asthma: A Randomized Triple-Blinded Placebo-Controlled Trial

ABSTRACT

Objective: To study whether addition of pidotimod to inhaled corticosteroid (ICS) therapy enhances control in children with persistent asthma, as compared to ICS therapy alone. Design: Triple-blinded, randomized controlled trial. Setting: Allergy and Asthma Clinic, Department of Pediatrics, at a tertiary care hospital between May, 2018 and June, 2019. Patients 79 children (5-12 years) with newly diagnosed persistent asthma as per Global Initiative for Asthma guidelines. Interventions: Children received 7 mL twice-a-day for 15 day, followed by 7 mL once-a-day for 45 days of either pidotimod (n=39) or placebo (n=40). In addition, both groups received inhaled budesonide via metered dose inhaler and spacer, throughout the study. Children were followed up every 4 weeks for a total of 12 weeks. At each follow-up visit, peak expiratory flow (PEF) and asthma symptom score and medicine adverse effects were recorded. Main outcome measures: Change in PEF at 12 weeks compared to baseline. Secondary outcomes were PEF at each follow-up visit, asthma symptom score at each visit, change in asthma symptom score at 12 weeks, and adverse event profile. Results: The median (IQR) change in PEF (from baseline to 12 weeks) was 13.0% (0.8%, 28.3%) in pidotimod group (n=35) vs 17.7% (4.3%, 35.2%) in placebo group (n=35) (P=0.69). All the secondary outcomes were also comparable between the two groups. There were no significant adverse effects observed. Conclusions: Addition of pidotimod for 8 weeks to standard ICS therapy did not enhance asthma control compared to placebo.