Efficacy and Safety of Pidotimod in Childhood Wheezing: A Pilot Study

Background: There is a growing need for effective therapies for the management of wheezing in the pediatric population. Aim: We conducted a pilot, mono-centre, prospective, follow-up study to assess the efficacy and the safety of Pidotimod (PDT) in the treatment of wheezing in children. Methods: Globally, 90 children (M:F=58:62, mean age 4.7}1.64 years) with recurrent viral wheezing were enrolled in the study between October-November 2018. At baseline, children received treatment with PDT as 1 vial of 400mg daily for 3 consecutive months. We evaluated the therapeutic efficacy of PDT treatment at the end of 3 (T3) months of therapy as well as the long efficacy and preventive efficacy of PDT treatment during a 3-months follow-up (T6) by using the following outcomes: (i) How many patients showed one or more episodes of viral wheezing? (ii) How many patients were taking concomitant medications (ICS, SABA, antibiotics)? (iii) How many patients required ED visits? (iv) How many patients required hospitalization? Results: A significant decrease in the number of patients with at least one or more episodes of wheezing and taking antibiotics was recorded after 3 months of treatment, and a further significant decrease for both outcomes was reported at 3-months follow-up period (p<0.05). Differently, after 3 months of treatment, we found a significant decrease in the number of patients taking ICS and SABA and in the number of patients requiring ED visits and/or hospitalization (p<0.05); however, for all these outcomes, no further significant decrease was reported at follow-up period. Conclusion: We first showed that the administration of PDT is useful in the management of patients with recurrent viral wheezing because we found a reduction in the number of patients requiring ED visits and/or hospitalization as well as the number of patients taking drugs during the treatment period. Moreover, to date, we found a long-term clinical effect over three months after treatment suspension counteracting the recurrence of the disease.