Efficacy Of Bacterial Lysate In Children With Allergic Rhinitis

• Status: Completed
• Trial end date: 2018-08-12
• Target enrollment: 0
• Participant gender: All

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.

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

Details

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

Criteria

Inclusion Criteria:

1. Children of both genders aged 5 to 17 years.

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

3. 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.

4. 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.

5. Proper use of PMBL sublingual tablets.

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

Exclusion Criteria:

1. Patient received mechanical or any other polyvalent bacterial lysate immunostimulation within the previous 12 months before visit 1.

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

3. Vaccination performed within 3 months before the beginning of the study.

4. Deficiencies in cellular and humoral immunity.

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

6. Pregnant or breastfeeding woman.

7. Other chronic conditions of the nose or nasal sinuses.