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NCT Number: NCT05677763

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Respiratory Tract Infections Infections Respiratory Tract Diseases Wheezing Lower Respiratory Illness

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Ludwig Maximilians Universität München, München, Bavaria, Germany

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About this study

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.

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • Injection or oral administration of steroids within 4 weeks prior to study enrolment.
  • 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.

Treatment and study plan

OM-85

Drug

Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month)

Placebo

Drug

Subjects will be administered Placebo once daily. (10 days per month)

Primary outcomes

  1. Rate of respiratory tract infections (RTIs)

    Time frame: 12 Months

    The number of RTIs experienced by a subject during the Treatment period will be assessed.

Secondary outcomes

  1. Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject

    Time frame: 12 Months

    The number of wLRIs experienced by a subject during the Treatment period will be assessed. This is the key secondary endpoint

  2. Rate of wLRIs

    Time frame: 18 Months

    The number of wLRIs experienced by a subject during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  3. Rate of respiratory tract infections (RTIs)

    Time frame: 18 Months

    The number of RTIs experienced by a subject during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  4. Proportion of subjects with recurrent RTIs

    Time frame: 12 Months

    The proportion of subjects experiencing ≥3 RTIs during the first 6 months of treatment, and the number of subjects experiencing ≥4 RTIs during the full 12-month Treatment period will be assessed.

  5. Proportion of subjects with wLRIs

    Time frame: 18 Months

    The proportion of subjects with wLRIs during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  6. Rate of severe wheezing lower respiratory illness (SwLRIs)

    Time frame: 18 Months

    The number of SwLRIs experienced by a subject during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  7. Proportion of subjects with SwLRIs

    Time frame: 18 Months

    The proportion of subjects with SwLRIs during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  8. Time to first, second and third RTI and wLRI

    Time frame: 18 Months

    Time to first, second and third RTI and wLRI will be assessed.

  9. Mean duration in days per RTI

    Time frame: 18 Months

    Mean duration in days per RTI during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  10. Mean duration in days per wLRI

    Time frame: 18 Months

    Mean duration in days per wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  11. Number of outpatient medical visits

    Time frame: 18 Months

    Number of outpatient medical visits (hospitalisations, visits to emergency rooms, or to a physician/health care provider) due to an RTI and/or a wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  12. Number of absent days from day-care

    Time frame: 18 Months

    Number of absent days from day-care due to an RTI and/or a wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  13. Number of antibiotic treatments for a respiratory event

    Time frame: 18 Months

    Number of antibiotic treatments for a respiratory event during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  14. Duration of antibiotic treatments for a respiratory event

    Time frame: 18 Months

    Duration of antibiotic treatments for a respiratory event during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  15. Number of systemic corticosteroids, inhaled corticosteroids (ICS) and β2-agonist treatments for a wLRI

    Time frame: 18 Months

    Number of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  16. Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI

    Time frame: 18 Months

    Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  17. Symptom duration as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire

    Time frame: 18 Months

    Symptom duration during the Treatment period, during the Observational period, and during the whole study period will be assessed using WURSS-K questionnaire. Adapted WURSS-K is a valid and reliable illness-specific quality of life instrument that evaluates the impacts of RTIs on children.

  18. Symptom types as per the adapted WURSS-K questionnaire

    Time frame: 18 Months

    Symptom types during the Treatment period, during the Observational period, and during the whole study period will be assessed using WURSS-K questionnaire. Adapted WURSS is a valid and reliable illness-specific quality of life instrument that evaluates the impacts of RTIs on children.

  19. Symptom severity as per the adapted WURSS-K questionnaire

    Time frame: 18 Months

    Symptom severity during the Treatment period, during the Observational period, and during the whole study period will be assessed using WURSS-K questionnaire. Adapted WURSS is a valid and reliable illness-specific quality of life instrument that evaluates the impacts of RTIs on children.

  20. Proportion of subjects who have not used antibiotics as rescue medication for RTI

    Time frame: 18 Months

    The proportion of subjects who have not used antibiotics as rescue medication for RTI during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  21. Proportion of subjects who have not been hospitalised for an RTI

    Time frame: 18 Months

    The proportion of subjects who have not been hospitalised for an RTI during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  22. Proportion of subjects who have not been administered a systemic corticosteroid for wLRI

    Time frame: 18 Months

    The proportion of subjects who have not been administered a systemic corticosteroid for wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.

  23. Proportion of subjects who have not been hospitalised for more than 1 day for wLRI

    Time frame: 18 Months

    The proportion of subjects who have not been hospitalised for more than 1 day for wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.

Other outcomes

  1. Number of subjects with adverse events and serious adverse event

    Time frame: 18 Months

    The safety of short- and long-term treatment with OM-85 vs. placebo in children aged between 6 months and 5 years with recurrent RTIs associated with wLRI during the Treatment period and during the Observational period will be assessed.

Sponsors and collaborators

Lead sponsor

OM Pharma SA

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 10, 2023
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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