Efficacy and Safety of Pidotimod in the Prevention of Recurrent Respiratory Infections in Children: A Multicentre Study

Abstract

Acute respiratory infections (ARI) still represent a big challenge for paediatricians, especially in those children defined as "ailed" as they are more susceptible to such kinds of disease. In this paediatric population, the immune system is still under-developed with an evident alteration in cytokine levels. A clinical study was carried out in 5 sites in Russia with the intention to enroll children particularly susceptible to contract respiratory infections (defined as "ailing"), assigning them to a treatment group with pidotimod in comparison with a control group, treating them for 30 days and observing the reduction in the number of ARI episodes throughout the follow-up period (6 months). Moreover, changes in serum immunological markers were evaluated at baseline and 30 days after treatment discontinuation. One hundred and fifty-seven ailing children were enrolled and assigned to two arms: a main pidotimod treatment group or a control group. The percentage of incidence of ARIs in the observation period at three different time points was statistically significant (p < 0.05). At the end of the follow-up period (after 6 months), ARIs had developed in 72 children (92.3%) in the main group and in 79 patients (100%) in the control group. Concerning changes of the immunological markers, the treatment group showed a better profile of normalization compared to the control group. The 30-day pidotimod therapy course led to improvement/reduction in the rate of acute respiratory infection recurrence in ailing children within a 3-month period, with a quick elimination of symptoms and signs of infection and, as a result, a faster recovery. The normalisation of the content of the pro-inflammatory cytokine interleukin-8 confirmed the immune-modulatory effect of the investigational drug, underlying its prophylactic effect.

Promising approaches for the treatment and prevention of viral respiratory illnesses

“…76,77 Pidotimod, a synthetic dipeptide molecule, induces a variety of immunomodulatory effects 78,79 and has shown some efficacy in preventing RTIs, although this was not always confirmed. 80,81 Probiotic supplementation has been shown to reduce the incidence, duration, and severity of upper respiratory tract infections through immune modulation 82 and in particular rhinovirus infection through altering nasal innate inflammatory responses. 83 Vitamin D (25-hydroxyvitamin D) has a modulatory role in host defense, inflammation, immunity, and epithelial repair after respiratory tract infections.…”

Echinacea purpurea Extract Affects the Immune System, Global Metabolome, and Gut Microbiome in Wistar Rats

“…Pidotimod has been definitely confirmed to have immunomodulatory activity on both innate and adaptive responses via acting on different immunological pathways (Esposito et al, 2015;Mameli et al, 2015;Namazova-Baranova et al, 2014). Pidotimod is also believed a safe immune stimulating agent by stimulating nonspecific immunity, humoral immunity and cellular immunity, with no serious adverse event occurred and even being used as a child medication (Licari et al, 2014).…”

Immunoactive preparations and regulatory responses in the respiratory tract: potential for clinical application in chronic inflammatory airway diseases

“…However, in a prospective multicenter trial, pidotimod reduced the number of respiratory infections during a three-month observation period in a mixed group of children over half of whom had atopic conditions including asthma (Table 1). But, there was no longer a significant difference at the 6-month follow-up [125].…”