Table 1 Pidotimod: clinical trials in children

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