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Table 1 Pidotimod: clinical trials in children

From: Pidotimod: the state of art

Prophylaxis with the novel immunomodulator Pidotimod reduces the frequency and severity of upper respiratory tract infections in children with Down’s Syndrome 26 children with Down’s Syndrome ↓ nasal secretions,  
↓ nasal obstruction
• M/F = 12/12 ↓ mucosal hyperemia
• From 3 to 13 years ↓ less recurrent inflammatory episodes
↓ days of fever and,
↓ in the use of antibiotics and antipyretics.
Immunomodulating activity of Pidotimod in children with Down Syndrome. 18 children ↑ activity of vaccine when co-administration  
• M/F = 14/4
• From 3 to 10 years
Changes of immune function in children with refractory mycoplasma pneumoniae pneumonia and effects of Pidotimod 66 children with Mycoplasma pneumoniae pneumonia ↓ of number of recurrence ↑ the number of T cells
↓ duration of symptoms ↑ the number
↓ duration of antibiotics treatment natural killer cells
Comparison of effects of Pidotimod and spleen aminopeptide on clinical symptoms and Th1/Th2 cytokines in children with RRI 86 children with recurrent respiratory infection ↓duration of symptoms ↓levels of inteleukin-4 ↑levels of INF γ
• M/F = 44/42 ↓ day of treatment
• Mean age control group 2.9 years
• Mean age treatment group 3.2 years
Observation of impact and efficacy of Pidotimod on serum interleukin-4 and gamma-interferon levels in children with asthm 52 children   ↓levels of inteleukin-4 ↑levels of INF γ
• Treatment group M/F = 20/16 mean age 9.2 years
• Control group M/F = 18/18 mean age 8.7 years
The effect of Pidotimod in the prevention and Treatment of Pediatric Bronchial Asthma 100 children   ↑ phagocytic activity
• treatment group M/F = 29/21 mean from 2 to 9 years ↑chemotaxis of macrophages and neutrophilis,
• Control group M/F = 26/24 from 2 to 10 years ↑NK cells ↑proliferation
of CD4+
The effect of Pidotimod on serum IL-4, IFN-gamma and IgE in asthmatic children 80 children   ↓level of IL-4,
• Treatment group M/F = 24/16 from 6 to 9 years ↓IgE level
↑level of IFN-gamma
• Control group M/F = 23/17 from 6 to 9 years
Immune modulator Pidotimod decreases the in vitro expression of CD30 in peripheral blood mononuclear cells of atopic asthmatic and normal children. 22 children   down-regulate CD30+
• M/F = 14/8
• mean age 6.2 years
Pidotimid may prevent recurrent respiratory infections in children 100 children ↓ the symptoms of upper and lower respiratory tract,  
• M/F = 49/51 ↓ the use of medications,
↓ loss of school days
• Mean age 4.9 years ↓ pediatric visits for RRI