Efficacy Of Bacterial Lysate In Children With Allergic Rhinitis

March 15, 2021 updated by: Kamil Janeczek, Medical University of Lublin

The Effect Of Polivalent Mechanical Bacterial Lysate On The Clinical Course Of Grass Pollen-Induced Allergic Rhinitis In Children

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, 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

Enrollment (Actual)

76

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lublin, Poland, 20-093
        • Department of Pulmonary Diseases and Children Rheumatology, Medical University of Lublin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ismigen
Treatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest.
Drug: Ismigen
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.
Other Names:
  • Polyvalent Mechanical Bacterial Lysate (PMBL)
Placebo Comparator: Placebo
Treatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest.
Drug: Placebo
Matched tablets without any active substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the severity of nasal SAR symptoms as assessed by Total Nasal Symptom Score (TNSS)
Time Frame: at baseline, at 1-month, at 2-months and at 3-months

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.
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)
Time Frame: at baseline, at 1-month, at 2-months and at 3-months

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.
at baseline, at 1-month, at 2-months and at 3-months
Change in the nasal obstruction using Peak Nasal Inspiratory Flow (PNIF)
Time Frame: at baseline, at 2-months and at 3-months

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.
at baseline, at 2-months and at 3-months
Change in the severity of nasal SAR symptoms as assessed by Visual Analogue Scale (VAS)
Time Frame: at baseline, at 2-months and at 3-months
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.
at baseline, at 2-months and at 3-months
Change in the severity of ocular SAR symptoms as assessed by Visual Analogue Scale (VAS)
Time Frame: at baseline, at 2-months and at 3-months
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.
at baseline, at 2-months and at 3-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasal eosinophil count
Time Frame: at baseline, at 2-months and at 3-months
To assess the change in the number of eosinophils in nasal smears.
at baseline, at 2-months and at 3-months
Specific immunoglobulin E concentration
Time Frame: at baseline, at 2-months and at 3-months
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.
at baseline, at 2-months and at 3-months
Frequency of oral H1-antihistamines use
Time Frame: from baseline, up to the 3-month time point
To assess the mean number of days of oral H1-antihistamines use for the relief of SAR symptoms.
from baseline, up to the 3-month time point
Frequency of intranasal corticosteroids use
Time Frame: from baseline, up to the 3-month time point
To assess the mean number of days of intranasal corticosteroids use for the relief of SAR symptoms.
from baseline, up to the 3-month time point
Incidence of treatment emergent adverse events [safety and tolerability]
Time Frame: from baseline, up to the 3-month time point
Incidence, frequency and severity of treatment emergent adverse events.
from baseline, up to the 3-month time point
Incidence of treatment emergent adverse events leading to discontinuation [safety and tolerability]
Time Frame: from baseline, up to the 3-month time point
The number of participants with adverse events leading to discontinuation.
from baseline, up to the 3-month time point
Time to discontinuation due to treatment emergent adverse events [safety and tolerability]
Time Frame: From date of randomization until the date of occurrence of an adverse event leading to discontinuation, assessed up to 3 months
To assess the time that has elapsed since treatment initiation to the occurrence of an adverse event leading to discontinuation.
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]
Time Frame: at baseline and at 3-months
Complete blood count assessment at baseline and at 3-months.
at baseline and at 3-months
Incidence of treatment emergent abnormalities in physical examination findings [safety and tolerability]
Time Frame: at baseline, at 2-months and at 3-months
Observe skin, lymph nodes, ears, eyes, nose, throat, cardiac and pulmonary status, abdomen and extremities for any abnormalities.
at baseline, at 2-months and at 3-months
Incidence of treatment emergent abnormalities in pulse rate [safety and tolerability]
Time Frame: at baseline, at 2-months and at 3-months
Measure resting pulse rate as beats per minute.
at baseline, at 2-months and at 3-months
Incidence of treatment emergent abnormalities in blood pressure [safety and tolerability]
Time Frame: at baseline, at 2-months and at 3-months
Measure systolic and diastolic blood pressure (in mmHg).
at baseline, at 2-months and at 3-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lublin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 22, 2018

Primary Completion (Actual)

July 20, 2018

Study Completion (Actual)

August 12, 2018

Study Registration Dates

First Submitted

February 10, 2020

First Submitted That Met QC Criteria

February 12, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KE-0254/41/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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