Efficacy Of Bacterial Lysate In Children With Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluate the efficacy of Polyvalent Mechanical Bacterial Lysate (PMBL - Ismigen)
      to improve the clinical course of grass pollen-induced allergic rhinitis (using: TNSS, TOSS,
      VAS, PNIF) in children aged 5 to 17. Half of the 70 participants will receive PMBL while the
      other half will receive placebo.
    

Detailed description: 
      Seasonal allergic rhinitis (SAR) is caused by the allergens of wind-pollinated plants, and in
      Poland mainly by grass pollen allergens. During the grass pollen season, patients may suffer
      from fatigue, weakness, lack of fitness, difficulty in sleeping and reduced performance at
      school. In people allergic to the above-mentioned pollen, the disease significantly reduces
      the quality of life and requires intensive treatment in the pollen period.

      Due to the high incidence of allergic rhinitis, the negative impact of the disease on the
      quality of life, and incomplete effectiveness of previously available therapeutic methods,
      new methods of treatment are being developed. Recent research highlights the immunoregulatory
      potential of bacterial lysates, indicating the possibility of their future use in the
      prevention and treatment of allergic diseases, including atopic dermatitis, allergic
      rhinitis, and asthma. However, so far no randomized, double-blind, placebo-controlled, study
      with bacterial lysate in children's SAR therapy has been conducted.

      The main aim of this study was to evaluate the clinical course of the pollen allergic
      rhinitis, caused by grass pollen allergens in children during the grass pollen season,
      treated with polyvalent mechanical bacterial lysate (PMBL). The approval of the Bioethics
      Committee at the Medical University in Lublin was obtained for the study.

      Seventy children with SAR were enrolled to this study and were randomly assigned to the PMBL
      group (n=35) and placebo group (n=35). Three visits took place as part of the study: at the
      beginning of the grass pollen season, at the peak, and at the end of the season. The time
      frame of the grass pollen season for south-eastern Poland was determined using the "95%"
      method on the basis of measurements of grass pollen concentration in the atmospheric air,
      which were obtained from the Environmental Allergy Research Centre in Warsaw.

      Nasal and ocular SAR symptoms were recorded by parents of children in the daily patient diary
      according to the standard scoring systems (TNSS, total nasal symptom score and TOSS, total
      ocular symptom score), and their intensity was also evaluated during three visits using VAS
      (visual analogue scale). At each visit, peak nasal inspiratory flow (PNIF) was also measured.

      In order to determine the mechanism responsible for the possible effects of PMBL, samples
      were taken from patients for additional testing: nasal smears for the presence of eosinophils
      and nasal lavage fluids for the presence of allergen-specific IgE (asIgE) against timothy
      grass pollen allergens.
    

Intervention name(s): Ismigen; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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) - sublingual use 1 tablet per day over 10 days for 3 successive months.; Matched tablets without any active substance.
Other intervention name(s): Polyvalent Mechanical Bacterial Lysate (PMBL)
Intervention MeSH terms: Broncho-Vaxom
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: allergic rhinitis; seasonal allergic rhinitis; children; grass pollen season; bacterial lysate; Th2 inflammation; eosinophils; specific immunoglobulin E