OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness

O

OM Pharma

Status and phase

Enrolling
Phase 4

Conditions

Wheezing Lower Respiratory Illness
Respiratory Tract Infections

Treatments

Drug: Placebo
Drug: OM-85

Study type

Interventional

Funder types

Industry

Identifiers

NCT05677763
2022-000886-42 (EudraCT Number)
BV-2020/08

Details and patient eligibility

About

This study will assess the efficacy and safety of OM-85 compared to placebo in reducing the number of respiratory tract infections (RTIs) in children aged between 6 months and 5 years.

Full description

This is a Phase 4, randomised, double-blind, placebo-controlled study to assess the efficacy and safety of short- and long-term treatment with OM-85. The study will consist of screening (up to 20 days before randomisation), Treatment period of 12 months, and an Observational period of 6 months. A total of 426 subjects will be randomised in the study. The subjects will be randomised in a ratio of 1:1:1 ratio to receive either OM-85 for 12 consecutive months (BV-12 arm), or OM-85 for 3 consecutive months followed by matching placebo for 9 consecutive months (BV-3 arm), or placebo for 12 consecutive months (Placebo arm). The expected duration of subject participation is 18 months (+20 days)

Enrollment

426 estimated patients

Sex

All

Ages

6 months to 5 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Children of either gender aged between 6 months and 5 years, at Baseline/Randomisation (Visit 2) inclusive.
  • For children ≥1 year of age, ≥4 RTIs (as reported by parents or LAR of subject), including ≥2 episodes of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 12 months prior to enrolment.

OR

  • For children <1 year of age, ≥2 RTIs (as reported by parents or LAR of subject), including ≥1 episode of wLRIs (including ≥1 triggering hospitalisation or medical visit) within 6 months prior to enrolment.
  • Parents or LAR of subject have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures.

Exclusion criteria

  • Anatomic alterations of the respiratory tract.

  • Other chronic respiratory diseases (e.g., tuberculosis, cystic fibrosis).

  • Any autoimmune disease.

  • HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).

  • Known severe congenital heart disease.

  • Haematologic diseases.

  • Liver or kidney failure.

  • New-borns before 34 weeks of gestational age.

  • Malnutrition as per World Health Organization (WHO) definition.

  • Any known neoplasia or malignancy.

  • Treatment with the following medications:

    1. Injection or oral administration of steroids within 4 weeks prior to study enrolment.
    2. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to study enrolment.
  • Previous use within last 6 months of enrolment or ongoing use of bacterial lysates.

  • Any major surgery within the last 3 months prior to study enrolment.

  • Known allergy or previous intolerance to investigational medicinal products (IMP).

  • Any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study.

  • Other household members have previously been randomised in this clinical study.

  • Subjects' families expected to relocate out of study area within 24 months of the initiation of the study.

  • Currently enrolled in or has completed any other investigational device or drug study or receiving other investigational agent(s) within <30 days prior to screening.

  • Parents or legally acceptable representative (LAR) who do not have access to internet connection.

  • Wheezing documented to be caused by gastroesophageal reflux.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

426 participants in 3 patient groups, including a placebo group

BV-12
Experimental group
Description:
Subjects will receive OM-85 treatment for 12 consecutive months. (10 days per month)
Treatment:
Drug: OM-85
BV-3
Experimental group
Description:
Subjects will receive OM-85 treatment for 3 consecutive months, followed by matching placebo for 9 consecutive months. (10 days per month)
Treatment:
Drug: OM-85
Placebo
Placebo Comparator group
Description:
Subjects will receive matching placebo for 12 consecutive months. (10 days per month)
Treatment:
Drug: Placebo

Trial contacts and locations

40

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Central trial contact

Lorenz Lehr

Data sourced from clinicaltrials.gov

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