Status:
COMPLETED
Efficacy Of Bacterial Lysate In Children With Allergic Rhinitis
Lead Sponsor:
Medical University of Lublin
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief 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 c...
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,...
Eligibility Criteria
Inclusion
- 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 PMBL sublingual tablets.
- Written informed consent obtained from parents/guardians before any study related procedures are performed.
Exclusion
- Patient received mechanical or any other polyvalent bacterial lysate immunostimulation within the previous 12 months before visit 1.
- Patient received oral/subcutaneous allergen-immunotherapy within the previous 3 years before the start of the study.
- Vaccination performed within 3 months before the beginning of the study.
- Deficiencies in cellular and humoral immunity.
- Treatment with systemic corticosteroids within the last 6 months before the start of the study.
- Pregnant or breastfeeding woman.
- Other chronic conditions of the nose or nasal sinuses.
Key Trial Info
Start Date :
April 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2018
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT04270552
Start Date
April 22 2018
End Date
August 12 2018
Last Update
March 17 2021
Active Locations (1)
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1
Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin
Lublin, Poland, 20-093