Efficacy Of Bacterial Lysate In Asthmatic Children (EOLIA)

September 3, 2015 updated by: Lallemand Pharma AG

Influence of Polyvalent Mechanical Bacterial Lysate ISMIGEN® on Clinical Course of Asthma and Related Immunological Parameters in Asthmatic Children (EOLIA Study): Randomised Double-blind Placebo-controlled Multicentre Parallel-group Study

This study evaluate the efficacy of Mechanical Bacterial Lysate (PMBL - Ismigen®) to improve the asthma control level (ACT score) as add-on treatment to routine asthma treatment in children aged 6 to 16 with uncontrolled or partly controlled asthma. Half of the 150 participants will receive Ismigen® and their current asthma therapy while the other half will receive Placebo and their current asthma treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Acute and recurrent respiratory infections of the upper and middle respiratory tracts in the paediatric population of asthmatic patients represent a leading clinical burden, particularly during the winter. Respiratory tract infections, mainly viral infection are important factors that exacerbate asthma course in children. Currently no clinical data demonstrated the benefit of oral or sublingual bacterial lysates on asthma clinical course in children apart from one trial with OM-85 BV (Bronchovaxom®) suggesting reduced number and duration of infection-related wheezing attacks in children with asthma wheezing.

Therefore it was hypothesized that PMBL (Ismigen®) used in asthmatic children should significantly improve asthma course and control. A seasonal approach of active prevention, based on full-fledged antibacterial oral vaccination would be useful to show the potential benefit of this type of products.

The Primary objective was to assess the benefit of Ismigen® versus Placebo on the mean ACT score after administration of a Polyvalent Mechanical Bacterial Lysate (PMBL - Ismigen®) as add-on to routine asthma treatment.

Secondary objectives investigated:

  • the potential reduction (vs Placebo) of number of asthma exacerbations, time to first event with Ismigen®;
  • the potential decrease in number of respiratory tract infections during the observation period (3-month treatment and 6-month follow-up) after treatment;
  • the specific changes occurring in a panel of immunological markers as the result of Ismigen® effect (subset of 48 patients).

Study Type

Interventional

Enrollment (Actual)

150

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
      • Chelm, Poland, 22-100
        • LASERMED Diagnosis and Treatment Centre
      • Lublin, Poland, 20-093
        • Children University Hospital - Pneumology and Rheumatology Dept
      • Lublin, Poland, 20-095
        • ALERGOTEST s.c. Medical Centre
      • Zawadzkie, Poland, 47-120
        • Medical Centre Lucyna and Andrzej Dymek

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

6 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Children of both genders aged 6 to 16 years.
  2. Allergic asthma diagnosis with at least one perennial allergen according to the Global Strategy for Asthma Management and Prevention (GINA 2012 guidelines) prior to screening visit.
  3. Patient shows clinical characteristics of partly controlled or uncontrolled asthma according to GINA 2012.
  4. Already treated with SABA prn and ICS or ICS + LABA during the previous 3 months.
  5. Patient shows antigen-specific IgE against HDM ≥ class 2 or positive skin prick test or RAST for at least one perennial allergen.
  6. Patient who had at least 2 exacerbations of asthma within the 12-mo period before V1.
  7. Patient not treated with Polyvalent Mechanical Bacterial Lysate (Ismigen®) within the previous 6 months prior to Visit 1.

Exclusion Criteria:

  1. Patient received mechanical or any other bacterial lysate immunostimulation within the previous 6 months before Visit 1.
  2. Patient received oral/subcutaneous allergen-immunotherapy within the previous 6 months before Visit 1.
  3. History of near fatal asthma (e.g. brittle asthma, hospitalization for asthma exacerbation in Intensive Care Unit).
  4. Pregnant or breastfeeding woman.

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: Prevention
  • 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
Biological: ISMIGEN
Tablets of 30 billion organisms/mg - 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
Biological: PLACEBO
Matched tablets without any active substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in asthma control level (mean ACT or P-ACT) score
Time Frame: at 3-months
The main criterion is the improvement in mean ACT/P-ACT score versus baseline (between-groups comparison)
at 3-months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time-dependent change in asthma control level (mean ACT or P-ACT) score
Time Frame: at 6-months and at 9-months
Improvement in ACT/P-ACT score versus baseline (between-groups comparison)
at 6-months and at 9-months
Number of respiratory infections occurring during the 3-mo treatment and the 6-mo follow-up after treatment
Time Frame: at 3-months, at 6-months and at 9-months
Comparison of frequency of events between groups during the observation period.
at 3-months, at 6-months and at 9-months
Time to first mild or severe asthma exacerbation
Time Frame: From baseline
To assess the exacerbation-free time after baseline (between-groups comparison)
From baseline
Standardized mean daily dose of Inhaled Corticosteroids (ICS) used
Time Frame: From baseline, up to the 9-month time point
To assess the amount of current asthma treatment (ICS) required to maintain a stable asthma control level (between-groups comparison)
From baseline, up to the 9-month time point
Frequency of short acting beta-2 agonists use as rescue medication
Time Frame: From baseline, up to the 9-month time point
To assess the necessary amount of rescue medication to cure exacerbations (between-groups comparison)
From baseline, up to the 9-month time point
Serum Immunoglobulins
Time Frame: At baseline and at 3-months
Levels of total IgE, IgA, IgM, IgG (including IgG1, IgG2, IgG3, IgG4) (between-groups comparison, biology subset)
At baseline and at 3-months
Serum antibacterial antibodies concentration
Time Frame: At baseline, at 3-weeks and at 3-months
Specific immunological response to Ismigen vaccination: IgG levels of Streptococcus pneumonia, Haemophilus Influenzae, Staphylococcus aureus, Klebsiella pneumonia, Streptococcus pyogenes, Klebsiella Ozenae, Streptococcus group A-G (between-groups comparison, biology subset)
At baseline, at 3-weeks and at 3-months
Blood Specific markers of Lymphocyte activation
Time Frame: At baseline and at 3-months
Levels of CD23 (B cells), CD25 (T cells) and CD69 (T, B and NK cells) (between-groups comparison, biology subset)
At baseline and at 3-months
Activation of CD4 T cells in peripheral blood
Time Frame: At baseline and at 3-months
Flow cytometric analyses of Foxp3 and CD25 expression as markers of conversion of T cells into nTreg and iTreg (between-groups comparison, biology subset)
At baseline and at 3-months
Specific T cells responses in peripheral blood mononuclear cells (PBMC)
Time Frame: At baseline, at 3-weeks and at 3-months
Number of vaccine specific T cells positive to IFN-gamma, IL-4, IL-13 assessed as spot-forming units by ELISPOT assay (between-groups comparison, biology subset)
At baseline, at 3-weeks and at 3-months
PAQLQ (Paediatric Asthma Quality of Life Questionnaire) and PACQLQ (Paediatric Asthma Caregivers Quality of Life Questionnaire)
Time Frame: At baseline and at 9-months
Patient and caregiver auto-questionnaires to assess the change in quality of life relative to asthma (between-groups comparison)
At baseline and at 9-months
Cumulative number of days with respiratory tract infections
Time Frame: From baseline, up to the 9-month time point
Cumulative number of days with an event (Between-groups comparison)
From baseline, up to the 9-month time point
Number of lost school days due to respiratory infections and to asthma exacerbations
Time Frame: From baseline, up to the 9-month time point
Cumulative number of days of absences (Between-groups comparison)
From baseline, up to the 9-month time point

Collaborators and Investigators

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

Sponsor

Lallemand Pharma AG

Investigators

  • Study Director: Frederic Durmont, MD, Lallemand Pharma International AG

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

July 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 31, 2015

First Submitted That Met QC Criteria

September 2, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 3, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LPI-1201

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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