At a glance
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The Effect of Immunostimulation With Polyvalent Mechanical Bacterial Lysate on Changes in the Concentration of iNKT Cells in Children With Allergic Rhinitis.
In Brief
A Phase 3 clinical trial evaluating Ismigen and Placebo for Allergic Rhinitis Due to Grass Pollen. Completed, enrolled 80 participants across 1 site.
Detailed Summary
The aim of the study is to assess the effect of polyvalent mechanical bacterial lysate (PMBL, Ismigen) on the clinical course of grass pollen-induced allergic rhinitis (using: total nasal symptom score, visual analogue scale, peak nasal inspiratory flow measurement) in children aged 5 to 17 and to assess changes in the concentration of iNKT cells under the influence of the therapy. Half of the 80 participants will receive PMBL while the other half will receive placebo.
Study Details
Timeline
Interventions
Sublingual tablets containing 7 mg of bacterial lysate from the following bacteria: Staphylococcus aureus, Haemophilus influenzae serotype B, Klebsiella pneumoniae, Klebsiella ozaenae, Neiserria catarrhalis, Streptococcus viridans, Streptococcus pyogenes, Streptococcus pneumoniae (6 strains: TY1/EQ11, TY2/EQ22, TY3/EQ14, TY5/EQ15, TY8/EQ23, TY47/EQ24).
Matched tablets without any active substance.