Study design
PMBL, grass pollen-induced AR
SECONDARY, RESOLUTION, POLAND
It was a 1:1 randomized, double-blind, placebo-controlled study in parallel groups (PMBL vs placebo). The study received a favorable opinion from the Bioethics Committee of the Medical University of Lublin (Resolution No KE-0254/251/2020, 26 November 2020) and was prospectively registered with ClinicalTrials.gov (Trial Registration No NCT04802616, 17 March 2021). The study was conducted in accordance with Good Clinical Practice standards, and the ethical principles that have their origin in the Declaration of Helsinki. The project was implemented in 3 centers in eastern Poland from 22 March 2021 to 29 October 2021.The primary objectives of this study were to evaluate the effectiveness of 3-month PMBL therapy in improving the clinical course of grass pollen-induced AR in children, and above all its effect on changes in the blood level of the γδT cell subsets: Th1-like, Th2-like, Th10-like, Th17-like, Treg-like; iNKT cell subsets: iNKT1, iNKT2, iNKT10, iNKT17, iNKTreg; cytotoxic T (Tc) cell subsets: Tc1, Tc2, Tc10, Tc17, Treg-like and to assess the relationship between the level of these lymphocytes and the severity of SAR symptoms assessed using the total nasal symptom score (TNSS).The secondary study objectives were to assess the effect of PMBL therapy on the need for oral H1-antihistamines and intranasal corticosteroids during the grass pollen season and to evaluate the safety and tolerability of this therapy.