Status:
COMPLETED
The Influence of Nonspecific Immunostimulation on Changes in the Concentration of iNKT Cells
Lead Sponsor:
Medical University of Lublin
Conditions:
Allergic Rhinitis Due to Grass Pollen
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief 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 scor...
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 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
- 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.
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04802616
Start Date
March 22 2021
End Date
October 29 2021
Last Update
April 5 2022
Active Locations (1)
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1
Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin
Lublin, Poland, 20-093