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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Tract Infections; Wheezing Lower Respiratory Illness
• Intervention / Treatment: Drug: OM-85; Drug: Placebo

Detailed 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)

• Study Type: Interventional
• Enrollment (Estimated): 426
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Lorenz Lehr; Phone Number: +41 22 783 14 59; Email: lorenz.lehr@ompharma.com

Study Locations

• Germany
  • Bayern
    • München, Bayern, Germany, 80337
      • Recruiting
      • Ludwig Maximilians Universität München
    • Schönau Am Königssee, Bayern, Germany, 83471
      • Recruiting
      • Praxiszentrum Triftplatz - Pediatrics
  • Niedersachsen
    • Hanover, Niedersachsen, Germany, 30625
      • Active, not recruiting
      • Medizinische Hochschule Hannover
  • Nordrhein-Westfalen
    • Bochum, Nordrhein-Westfalen, Germany, 44791
      • Recruiting
      • St. Josef-Hospital
    • Cologne, Nordrhein-Westfalen, Germany, 50937
      • Recruiting
      • University Hospital Cologne AöR
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 40217
      • Active, not recruiting
      • Ev. Krankenhaus Düsseldorf
    • Moenchengladbach, North Rhine-Westphalia, Germany, 41236
      • Active, not recruiting
      • Praxis Köllges
    • Wesel, North Rhine-Westphalia, Germany, 46483
      • Not yet recruiting
      • Marien-Hospital Wesel gGmbH
  • Schleswig-Holstein
    • Lübeck, Schleswig-Holstein, Germany, 23538
      • Active, not recruiting
      • Universitätsklinikum Schleswig-Holstein Campus Lübeck
• Hungary
  • Balassagyarmat, Hungary, H-2660
    • Recruiting
    • Dr. Kenessey Albert Korhaz-Rendelointezet
  • Budapest, Hungary, 1083
    • Recruiting
    • Semmelweis University Faculty of Medicine I. Pediatric Clinic
  • Budapest, Hungary, 1089
    • Recruiting
    • Heim Pal Children's Hospital
  • Gyula, Hungary, 5700
    • Recruiting
    • Sanitas Diagnosztikai és Rehabilitációs Központ
  • Miskolc, Hungary, 3527
    • Recruiting
    • Futurenest Kft.
  • Csongrád
    • Szeged, Csongrád, Hungary, 6720
      • Recruiting
      • Aranyklinika Kft
• Italy
  • Bari, Italy, 70126
    • Recruiting
    • Osp.Pediatr.Giov.XXIII,AOUC P.Bari
  • Bergamo, Italy, 24127
    • Active, not recruiting
    • ASST Papa GiovanniXXIII,Mat.Inf.Ped
  • Parma, Italy, 43100
    • Recruiting
    • Azienda ospedalo universitaria
  • Pavia, Italy, 27100
    • Recruiting
    • Universita degli Studi di Pavia - Fondazione IRCCS Policlini
  • Pisa, Italy, 56126
    • Active, not recruiting
    • University of Pisa
• Poland
  • Kraków, Poland, 31-411
    • Recruiting
    • Centrum Medyczne Promed
  • Rabka-Zdrój, Poland, 34-700
    • Withdrawn
    • Instytut Gruzlicy i Chorob Pluc Oddzial Terenowy
  • Skierniewice, Poland, 96-100
    • Recruiting
    • ETG Skierniewice
  • Warszawa, Poland, 01-231
    • Recruiting
    • Przychodnia Specjalistyczna Prosen-Med NZOZ
  • Lódzkie
    • Łódź, Lódzkie, Poland, 90-329
      • Recruiting
      • WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka
  • Malopolskie
    • Tarnów, Malopolskie, Poland, 33-100
      • Recruiting
      • ALERGO-MED Specjalistyczna Przychodnia Lekarska Spolka z o.o.
  • Podlaskie
    • Bialystok, Podlaskie, Poland, 15-879
      • Recruiting
      • Nzoz E-Vita
  • Slaskie
    • Siemianowice Śląskie, Slaskie, Poland, 41-103
      • Recruiting
      • NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska
  • Swietokrzyskie
    • Skarżysko-Kamienna, Swietokrzyskie, Poland, 26-110
      • Active, not recruiting
      • NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.
• Switzerland
  • Geneva, Switzerland, 1205
    • Active, not recruiting
    • Hôpitaux universitaires de Genève (HUG)
  • Zuerich, Switzerland, 8032
    • Active, not recruiting
    • Universitaets-Kinderklinik - Kinderspital Zuerich
  • Bern (de)
    • Bern, Bern (de), Switzerland, 3010
      • Recruiting
      • Inselspital Bern Kinderklinik
  • Vaud (fr)
    • Lausanne, Vaud (fr), Switzerland, 1011
      • Recruiting
      • CHUV-Centre Hopitalier Universitaire Vaudois
• United Kingdom
  • Edinburgh, United Kingdom, EH9 1LF
    • Active, not recruiting
    • Royal Hospital for Children and Young People
  • Leicester, United Kingdom, LE3 9QP
    • Withdrawn
    • University Hospitals Of Leicester Nhs Trust
  • London, United Kingdom, SE5 9RS
    • Recruiting
    • King's College Hospital
  • London, United Kingdom, E1 4NS
    • Recruiting
    • Royal London Hospital
  • Manchester, United Kingdom, M13 9WL
    • Active, not recruiting
    • Royal Manchester Children's Hospital - Paediatrics - Paediatrics
  • Nottingham, United Kingdom, NG7 2UH
    • Not yet recruiting
    • Nottingham University Hospitals NHS Trust - Queen's Medical Centre
  • East Sussex
    • Brighton, East Sussex, United Kingdom, BN2 5BE
      • Not yet recruiting
      • Brighton and Sussex University Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 5 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BV-12; Subjects will receive OM-85 treatment for 12 consecutive months. (10 days per month)	Drug: OM-85; Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month)
Experimental: BV-3; Subjects will receive OM-85 treatment for 3 consecutive months, followed by matching placebo for 9 consecutive months. (10 days per month)	Drug: OM-85; Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month)
Placebo Comparator: Placebo; Subjects will receive matching placebo for 12 consecutive months. (10 days per month)	Drug: Placebo; Subjects will be administered Placebo once daily. (10 days per month)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of respiratory tract infections (RTIs)	The number of RTIs experienced by a subject during the Treatment period will be assessed.	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects with recurrent RTIs	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.	12 Months
Time to first, second and third RTI and wLRI	Time to first, second and third RTI and wLRI will be assessed.	18 Months
Mean duration in days per RTI	Mean duration in days per RTI during the Treatment period and during the Observational period will be assessed.	18 Months
Mean duration in days per wLRI	Mean duration in days per wLRI during the Treatment period and during the Observational period will be assessed.	18 Months
Number of outpatient medical visits	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 and during the Observational period will be assessed.	18 Months
Number of absent days from day-care	Number of absent days from day-care due to an RTI and/or a wLRI during the Treatment period and during the Observational period will be assessed.	18 Months
Number of antibiotic treatments for a respiratory event	Number of antibiotic treatments for a respiratory event during the Treatment period and during the Observational period will be assessed.	18 Months
Duration of antibiotic treatments for a respiratory event	Duration of antibiotic treatments for a respiratory event during the Treatment period and during the Observational period will be assessed.	18 Months
Number of systemic corticosteroids, inhaled corticosteroids (ICS) and β2-agonist treatments for a wLRI	Number of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI during the Treatment period and during the Observational period will be assessed.	18 Months
Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI	Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI during the Treatment period and during the Observational period will be assessed.	18 Months
Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject	The number of wLRIs experienced by a subject during the Treatment period will be assessed. This is the key secondary endpoint	12 Months
Rate of wLRIs	The number of wLRIs experienced by a subject during the Treatment period and during the Observational period will be assessed.	18 Months
Rate of respiratory tract infections (RTIs)	The number of RTIs experienced by a subject during the Treatment period and during the Observational period will be assessed.	18 Months
Proportion of subjects with wLRIs	The proportion of subjects with wLRIs during the Treatment period and during the Observational period will be assessed.	18 Months
Rate of severe wheezing lower respiratory illness (SwLRIs)	The number of SwLRIs experienced by a subject during the Treatment period and during the Observational period will be assessed.	18 Months
Proportion of subjects with SwLRIs	The proportion of subjects with SwLRIs during the Treatment period and during the Observational period will be assessed.	18 Months
Symptom duration as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire	Symptom duration during the Treatment period and during the Observational 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 Months
Symptom types as per the adapted WURSS-K questionnaire	Symptom types during the Treatment period and during the Observational 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.	18 Months
Symptom severity as per the adapted WURSS-K questionnaire	Symptom severity during the Treatment period and during the Observational 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.	18 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events and serious adverse event	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.	18 Months

Collaborators and Investigators

• Sponsor: OM Pharma SA

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: December 14, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Signs and Symptoms, Respiratory; Infections; Communicable Diseases; Respiratory Tract Infections; Respiratory Sounds
• Other Study ID Numbers: BV-2020/08; 2022-000886-42 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No