NCT02541331

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

11 months

First QC Date

August 31, 2015

Last Update Submit

September 3, 2015

Conditions

Allergic Asthma

Keywords

IgE-dependent asthma

Outcome Measures

Primary Outcomes (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)

    at 3-months

Secondary Outcomes (13)

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

    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

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

  • Time to first mild or severe asthma exacerbation

    From baseline

  • Standardized mean daily dose of Inhaled Corticosteroids (ICS) used

    From baseline, up to the 9-month time point

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

    From baseline, up to the 9-month time point

  • +8 more secondary outcomes

Study Arms (2)

ISMIGEN

EXPERIMENTAL

Treatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest

Biological: ISMIGEN

PLACEBO

PLACEBO COMPARATOR

Treatment over 3 successive months with one daily tablet over 10 days followed by 20 days of rest

Biological: PLACEBO

Interventions

ISMIGENBIOLOGICAL

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

Also known as: Polyvalent Mechanical Bacterial Lysate - PMBL
ISMIGEN
PLACEBOBIOLOGICAL

Matched tablets without any active substance.

PLACEBO

Eligibility Criteria

Age6 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

LASERMED Diagnosis and Treatment Centre

Chełm, 22-100, Poland

Location

Children University Hospital - Pneumology and Rheumatology Dept

Lublin, 20-093, Poland

Location

ALERGOTEST s.c. Medical Centre

Lublin, 20-095, Poland

Location

Medical Centre Lucyna and Andrzej Dymek

Zawadzkie, 47-120, Poland

Location

Related Publications (5)

  • 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.

    PMID: 20920766BACKGROUND

  • 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.

    PMID: 18805338BACKGROUND

  • 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.

    PMID: 18565953BACKGROUND

  • 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.

    PMID: 33472687DERIVED

  • 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.

    PMID: 29575037DERIVED

MeSH Terms

Interventions

Broncho-Vaxom

Study Officials

  • Frederic Durmont, MD

    Lallemand Pharma International AG

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 4, 2015

Study Start

July 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

PL(4)