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Efficacy Of Bacterial Lysate In Asthmatic Children

NCT02541331 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2015-09-07

No results posted yet for this study

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.

Conditions

  • Allergic Asthma

Interventions

BIOLOGICAL

ISMIGEN

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

BIOLOGICAL

PLACEBO

Matched tablets without any active substance.

Sponsors & Collaborators

  • Lallemand Pharma AG

    lead INDUSTRY

Principal Investigators

  • Frederic Durmont, MD · Lallemand Pharma International AG

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-06-30
Completion
2015-06-30

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02541331 on ClinicalTrials.gov