The study of OM-85 drug in paediatric recurrent respiratory tract infections with wheezing lower respiratory illness

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The company OM Pharma is commencing recruitment for the clinical trial of the OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness. This is a randomised, placebo-controlled, 3-Arm, double-blind, multicentre, phase 4 Study to Assess the Efficacy of OM-85 (Broncho-Vaxom) Short- and Long-Term Treatment vs. Placebo in the Prevention of Respiratory Tract Infections in Children Aged Between 6 Months and 5 Years With Wheezing Lower Respiratory Illness.

The conditions include respiratory tract infections and wheezing lower respiratory illness. The trial officially began on the December 12, 2022 and is planned to complete by June 30, 2025.

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.

The population that can be enrolled into this study:

  • Children of either gender aged between 6 months and 5 years, 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.

    The following patients cannot participate:
  • With anatomic alterations of the respiratory tract.
  • With other respiratory chronic diseases (e.g., tuberculosis, cystic fibrosis).
  • With any autoimmune disease.
  • Those having HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).
  • With congenital heart disease.
  • With haematologic diseases.
  • With liver or kidney failure.
  • New-borns before 34 weeks of gestational age.
  • With malnutrition as per World Health Organization (WHO) definition.
  • With any known neoplasia or malignancy.
  • Undergoing treatment with the following medications:
    1. Systemic or oral steroids (e.g., oral prednisolone) within 4 weeks prior to study enrolment.
    2. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to study enrolment.
  • With previous use within last 6 months of enrolment or ongoing use of bacterial lysates.
  • Underwent any major surgery within the last 3 months prior to study enrolment.
  • Having known allergy or previous intolerance to investigational medicinal products (IMP).
  • Having any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study.
  • Whsose other household members have previously been randomised in this clinical study.
  • Whose families expected to relocate out of study area within 24 months of the initiation of the study.
  • Being currently enrolled in or has completed any other investigational device or drug study or receiving other investigational agent(s) within  <30 days 30 days prior to screening.
  • With parents or legally acceptable representative (LAR) who do not have access to internet connection.

 

The link to the complete study profile: https://ichgcp.net/clinical-trials-registry/NCT05677763.

 

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