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Allergic AsthmaPhase 3EOLIANCT02541331

Efficacy Of Bacterial Lysate In Asthmatic Children

A Phase 3 study testing ISMIGEN in people with Allergic Asthma, run by Lallemand Pharma AG at 4 sites in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 6 to 16 years
Conditions the study is for
Allergic Asthma
What is being tested?
ISMIGEN
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
4 sitesPoland
Study dates
Jul 2014to Jun 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Poland4 sites

  • LASERMED Diagnosis and Treatment Centre

    Chełm, 22-100

  • Children University Hospital - Pneumology and Rheumatology Dept

    Lublin, 20-093

  • ALERGOTEST s.c. Medical Centre

    Lublin, 20-095

  • Medical Centre Lucyna and Andrzej Dymek

    Zawadzkie, 47-120

Other trials in Poland

About this study

Official title: 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.

Read the 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).
Conditions
Allergic Asthma
Being tested
ISMIGEN, PLACEBO
Keywords
IgE-dependent asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ISMIGENBiological

    Also called Polyvalent Mechanical Bacterial Lysate - PMBL

    Tablets of 30 billion organisms/mg - Sublingual use 1 tablet per day over 10 days for 3 successive months.

  • PLACEBOBiological

    Matched tablets without any active substance.

Study groups in NCT02541331
Study groupRoleWhat they receive
ISMIGENExperimentalTreatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest
Receives: Biological: ISMIGEN
PLACEBOPlacebo comparatorTreatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest
Receives: Biological: PLACEBO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in asthma control level (mean ACT or P-ACT) score

    The main criterion is the improvement in mean ACT/P-ACT score versus baseline (between-groups comparison)

    Measured: at 3-months

Secondary outcomes (13)

  1. Time-dependent change in asthma control level (mean ACT or P-ACT) score

    Improvement in ACT/P-ACT score versus baseline (between-groups comparison)

    Measured: at 6-months and at 9-months

  2. Number of respiratory infections occurring during the 3-mo treatment and the 6-mo follow-up after treatment

    Comparison of frequency of events between groups during the observation period.

    Measured: at 3-months, at 6-months and at 9-months

  3. Time to first mild or severe asthma exacerbation

    To assess the exacerbation-free time after baseline (between-groups comparison)

    Measured: From baseline

  4. Standardized mean daily dose of Inhaled Corticosteroids (ICS) used

    To assess the amount of current asthma treatment (ICS) required to maintain a stable asthma control level (between-groups comparison)

    Measured: From baseline, up to the 9-month time point

  5. Frequency of short acting beta-2 agonists use as rescue medication

    To assess the necessary amount of rescue medication to cure exacerbations (between-groups comparison)

    Measured: From baseline, up to the 9-month time point

  6. Serum Immunoglobulins

    Levels of total IgE, IgA, IgM, IgG (including IgG1, IgG2, IgG3, IgG4) (between-groups comparison, biology subset)

    Measured: At baseline and at 3-months

  7. Serum antibacterial antibodies concentration

    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)

    Measured: At baseline, at 3-weeks and at 3-months

  8. Blood Specific markers of Lymphocyte activation

    Levels of CD23 (B cells), CD25 (T cells) and CD69 (T, B and NK cells) (between-groups comparison, biology subset)

    Measured: At baseline and at 3-months

  9. Activation of CD4 T cells in peripheral blood

    Flow cytometric analyses of Foxp3 and CD25 expression as markers of conversion of T cells into nTreg and iTreg (between-groups comparison, biology subset)

    Measured: At baseline and at 3-months

  10. Specific T cells responses in peripheral blood mononuclear cells (PBMC)

    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)

    Measured: At baseline, at 3-weeks and at 3-months

  11. PAQLQ (Paediatric Asthma Quality of Life Questionnaire) and PACQLQ (Paediatric Asthma Caregivers Quality of Life Questionnaire)

    Patient and caregiver auto-questionnaires to assess the change in quality of life relative to asthma (between-groups comparison)

    Measured: At baseline and at 9-months

  12. Cumulative number of days with respiratory tract infections

    Cumulative number of days with an event (Between-groups comparison)

    Measured: From baseline, up to the 9-month time point

  13. Number of lost school days due to respiratory infections and to asthma exacerbations

    Cumulative number of days of absences (Between-groups comparison)

    Measured: From baseline, up to the 9-month time point

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2015 (estimated)
  2. Study startJul 2014
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
150 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02541331
Sponsor's protocol ID
LPI-1201
Acronym
EOLIA
Status last verified
Sep 2015
First submitted
31 Aug 2015
Last updated
7 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • Razi CH, Harmanci K, Abaci A, Ozdemir O, Hizli S, Renda R, Keskin F. The immunostimulant OM-85 BV prevents wheezing attacks in preschool children. J Allergy Clin Immunol. 2010 Oct;126(4):763-9. doi: 10.1016/j.jaci.2010.07.038.

    PubMed 20920766

  • Sly PD, Boner AL, Bjorksten B, Bush A, Custovic A, Eigenmann PA, Gern JE, Gerritsen J, Hamelmann E, Helms PJ, Lemanske RF, Martinez F, Pedersen S, Renz H, Sampson H, von Mutius E, Wahn U, Holt PG. Early identification of atopy in the prediction of persistent asthma in children. Lancet. 2008 Sep 20;372(9643):1100-6. doi: 10.1016/S0140-6736(08)61451-8.

    PubMed 18805338

  • Jackson DJ, Gangnon RE, Evans MD, Roberg KA, Anderson EL, Pappas TE, Printz MC, Lee WM, Shult PA, Reisdorf E, Carlson-Dakes KT, Salazar LP, DaSilva DF, Tisler CJ, Gern JE, Lemanske RF Jr. Wheezing rhinovirus illnesses in early life predict asthma development in high-risk children. Am J Respir Crit Care Med. 2008 Oct 1;178(7):667-72. doi: 10.1164/rccm.200802-309OC. Epub 2008 Jun 19.

    PubMed 18565953

  • Bartkowiak-Emeryk M, Emeryk A, Rolinski J, Wawryk-Gawda E, Markut-Miotla E. Impact of Polyvalent Mechanical Bacterial Lysate on lymphocyte number and activity in asthmatic children: a randomized controlled trial. Allergy Asthma Clin Immunol. 2021 Jan 20;17(1):10. doi: 10.1186/s13223-020-00503-4.

    PubMed 33472687

  • Emeryk A, Bartkowiak-Emeryk M, Raus Z, Braido F, Ferlazzo G, Melioli G. Mechanical bacterial lysate administration prevents exacerbation in allergic asthmatic children-The EOLIA study. Pediatr Allergy Immunol. 2018 Jun;29(4):394-401. doi: 10.1111/pai.12894.

    PubMed 29575037

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ISMIGEN in people with Allergic Asthma, run by Lallemand Pharma AG at 4 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in asthma control level (mean ACT or P-ACT) score (time frame: at 3-months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02541331, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015; AzTrials last refreshed its copy on 7 Nov 2026.

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