The Influence of Nonspecific Immunostimulation on Changes in the Concentration of iNKT Cells

• Status: Active, not recruiting
• Trial end date: 2021-09-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Lublin
• Treatments: Broncho-Vaxom

Criteria

Inclusion Criteria:

• Children of both genders aged 5 to 17 years.

• Children with grass pollen-induced allergic rhinitis recognized and treated according to current ARIA (Allergic Rhinitis and its Impact on Asthma) recommendations.

• Positive skin prick test to grass pollen allergens or positive specific IgE (defined as ≥ class 2, ≥ 0,70 kU/l) against timothy grass pollen allergens.

• Presentation of clinical symptoms of the allergic rhinitis (rhinorrhea, nasal congestion, nasal itching, sneezing) in at least two recent grass pollen seasons in Poland before inclusion in the study.

• Proper use of polyvalent mechanical bacterial lysate sublingual tablets.

• Not using drugs to alleviate the symptoms of allergic rhinitis in the last 7 days prior to enrollment in the study: intranasal glucocorticosteroids, intranasal, oral and ophthalmic antihistamines, intranasal and oral alpha-mimetics, intranasal anticholinergics, antileukotrienes and cromones.

• Written informed consent obtained from parents/guardians before any study related procedures are performed.

Exclusion Criteria:

• Patient received mechanical bacterial lysate immunostimulation within the previous 12 months before randomisation visit.

• Patient received chemical bacterial lysate immunostimulation within the previous 6 months before randomisation visit.

• Patient received oral/subcutaneous allergen-immunotherapy within the previous 3 years before the start of the study.

• Other chronic conditions of the nose or nasal sinuses.

• Severe nasal septum deviation.

• Acute respiratory infection in the 2 weeks prior to randomization visit.

• Treatment with systemic corticosteroids within the last 6 months before the start of the study.

• History of transfusion of blood, blood components or blood products.

• Pregnant or breastfeeding woman.

• Other chronic, uncontrolled diseases of the respiratory tract, gastrointestinal tract, urinary system, hematological diseases, immunodeficiency, cancer, cystic fibrosis.