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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
76
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.
Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin
Lublin, Poland
Change in the severity of nasal SAR symptoms as assessed by Total Nasal Symptom Score (TNSS)
The severity of nasal SAR symptoms (sneezing, runny nose, itchy nose and nasal congestion) were recorded by parents of children in the daily patient diary using the following scale: 0 = absent (no symptom); 1 = mild (symptom present, easily tolerated); 2 = moderate (awareness of symptom, bothersome but tolerable); 3 = severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping). The Total Nasal Symptom Score (sum of the 4 symptom scores) ranges from 0 (no symptoms) to 12 (worst symptoms). Weekly average TNSS values from the baseline period (beginning of the grass pollen season) and obtained 1 month (grass pollen season - significant intensification of SAR symptoms), 2 months (peak grass pollen season) and 3 months (3 weeks before the end of the grass pollen season) after initiating therapy were used for statistical analysis.
Time frame: at baseline, at 1-month, at 2-months and at 3-months
Change in the severity of ocular SAR symptoms as assessed by Total Ocular Symptom Score (TOSS)
The severity of ocular SAR symptoms (redness of the eyes, watery eyes, itching of the eyes) were recorded by parents of children in the daily patient diary using the following scale: 0 = absent (no symptom); 1 = mild (symptom present, easily tolerated); 2 = moderate (awareness of symptom, bothersome but tolerable); 3 = severe (symptoms hard to tolerate, interfere with daily activities and/or sleeping). The Total Ocular Symptom Score (sum of the 3 symptom scores) ranges from 0 (no symptoms) to 9 (worst symptoms). Weekly average TOSS values from the baseline period (beginning of the grass pollen season) and obtained 1 month (grass pollen season - significant intensification of SAR symptoms), 2 months (peak grass pollen season) and 3 months (3 weeks before the end of the grass pollen season) after initiating therapy were used for statistical analysis.
Time frame: at baseline, at 1-month, at 2-months and at 3-months
Change in the nasal obstruction using Peak Nasal Inspiratory Flow (PNIF)
Assessment of the nasal obstruction before (visit 1) and 2 months (visit 2) and 3 months (visit 3) after initiating therapy based on measurement of Peak Nasal Inspiratory Flow by Youlten Peak Flow Meter (Clement Clarke International, UK). The higher PNIF value, the smaller nasal obstruction.
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Time frame: at baseline, at 2-months and at 3-months
Change in the severity of nasal SAR symptoms as assessed by Visual Analogue Scale (VAS)
Assessment of the severity of nasal SAR symptoms before (visit 1) and 2 months (visit 2) and 3 months (visit 3) after initiating therapy with the use of Visual Analogue Scale.The patient was asked to indicate the severity of nasal SAR symptoms on a 100 mm Visual Analogue Scale, were 0 is no symptoms and 100 the worst possible symptoms.
Time frame: at baseline, at 2-months and at 3-months
Change in the severity of ocular SAR symptoms as assessed by Visual Analogue Scale (VAS)
Assessment of the severity of ocular SAR symptoms before (visit 1) and 2 months (visit 2) and 3 months (visit 3) after initiating therapy with the use of Visual Analogue Scale. The patient was asked to indicate the severity of ocular SAR symptoms on a 100 mm Visual Analogue Scale, were 0 is no symptoms and 100 the worst possible symptoms.
Time frame: at baseline, at 2-months and at 3-months
Nasal eosinophil count
To assess the change in the number of eosinophils in nasal smears.
Time frame: at baseline, at 2-months and at 3-months
Specific immunoglobulin E concentration
To assess the change in the level of allergen-specific immunoglobulin E (asIgE) against timothy grass pollen allergens in nasal lavage fluid and blood serum.
Time frame: at baseline, at 2-months and at 3-months
Frequency of oral H1-antihistamines use
To assess the mean number of days of oral H1-antihistamines use for the relief of SAR symptoms.
Time frame: from baseline, up to the 3-month time point
Frequency of intranasal corticosteroids use
To assess the mean number of days of intranasal corticosteroids use for the relief of SAR symptoms.
Time frame: from baseline, up to the 3-month time point
Incidence of treatment emergent adverse events [safety and tolerability]
Incidence, frequency and severity of treatment emergent adverse events.
Time frame: from baseline, up to the 3-month time point
Incidence of treatment emergent adverse events leading to discontinuation [safety and tolerability]
The number of participants with adverse events leading to discontinuation.
Time frame: from baseline, up to the 3-month time point
Time to discontinuation due to treatment emergent adverse events [safety and tolerability]
To assess the time that has elapsed since treatment initiation to the occurrence of an adverse event leading to discontinuation.
Time frame: From date of randomization until the date of occurrence of an adverse event leading to discontinuation, assessed up to 3 months
Incidence of treatment emergent clinical laboratory test abnormalities [safety and tolerability]
Complete blood count assessment at baseline and at 3-months.
Time frame: at baseline and at 3-months
Incidence of treatment emergent abnormalities in physical examination findings [safety and tolerability]
Observe skin, lymph nodes, ears, eyes, nose, throat, cardiac and pulmonary status, abdomen and extremities for any abnormalities.
Time frame: at baseline, at 2-months and at 3-months
Incidence of treatment emergent abnormalities in pulse rate [safety and tolerability]
Measure resting pulse rate as beats per minute.
Time frame: at baseline, at 2-months and at 3-months
Incidence of treatment emergent abnormalities in blood pressure [safety and tolerability]
Measure systolic and diastolic blood pressure (in mmHg).
Time frame: at baseline, at 2-months and at 3-months