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

NCT ID: NCT05677763

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 525 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-12
• Study Completion Date: 2026-09-16

Brief Summary

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.

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.

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).

Conditions

Respiratory Tract Infections; Wheezing Lower Respiratory Illness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

BV-12

Subjects will receive OM-85 treatment for 12 consecutive months. (10 days per month)

Group Type: EXPERIMENTAL

OM-85

Intervention Type: DRUG

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

BV-3

Subjects will receive OM-85 treatment for 3 consecutive months, followed by matching placebo for 9 consecutive months. (10 days per month)

Group Type: EXPERIMENTAL

OM-85

Intervention Type: DRUG

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

Placebo

Subjects will receive matching placebo for 12 consecutive months. (10 days per month)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

OM-85

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OM Pharma SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ludwig Maximilians Universität München

München, Bavaria, Germany

Clinical Research & Healthcare GmbH

Schönau am Königssee, Bavaria, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

St. Josef-Hospital

Bochum, North Rhine-Westphalia, Germany

University Hospital Cologne AöR

Cologne, North Rhine-Westphalia, Germany

Ev. Krankenhaus Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Praxis Köllges

Mönchengladbach, North Rhine-Westphalia, Germany

Marien-Hospital Wesel gGmbH

Wesel, North Rhine-Westphalia, Germany

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Schleswig-Holstein, Germany

Aranyklinika Kft

Szeged, Csongrád megye, Hungary

Dr. Kenessey Albert Korhaz-Rendelointezet

Balassagyarmat, , Hungary

Semmelweis Egyetem I.sz. Gyermekgyogyaszati Klinika

Budapest, , Hungary

Heim Pal Orszagos Gyermekgyogyaszati Intezet

Budapest, , Hungary

Sanitas Diagnosztikai és Rehabilitációs Központ

Gyula, , Hungary

Futurenest Kft.

Miskolc, , Hungary

Osp.Pediatr.Giov.XXIII,AOUC P.Bari

Bari, , Italy

ASST Papa GiovanniXXIII,Mat.Inf.Ped

Bergamo, , Italy

Azienda ospedalo universitaria

Parma, , Italy

Universita degli Studi di Pavia - Fondazione IRCCS Policlini

Pavia, , Italy

SO S.Chiara, AOU Pisana

Pisa, , Italy

Malopolskie Centrum Alergologii

Krakow, Lesser Poland Voivodeship, Poland

ALERGO-MED Specjalistyczna Przychodnia Lekarska Spolka z o.o.

Tarnów, Lesser Poland Voivodeship, Poland

Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna

Lublin, Lublin Voivodeship, Poland

WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka

Lodz, Lódzkie, Poland

NZOZ E-Vita

Bialystok, Podlaskie Voivodeship, Poland

Centrum Medyczne Pratia Czestochowa

Częstochowa, Silesian Voivodeship, Poland

NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska

Siemianowice Śląskie, Silesian Voivodeship, Poland

Centrum Medyczne PROMED

Krakow, , Poland

Podkarpacki Osrodek Pulmonologii i Alergologii Sp. z o.o.

Rzeszów, , Poland

Velocity Skierniewice Sp. z o.o.

Skierniewice, , Poland

Przychodnia Specjalistyczna Prosen-Med NZOZ

Warsaw, , Poland

NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.

Skarżysko-Kamienna, Świętokrzyskie Voivodeship, Poland

CHUV-Centre Hopitalier Universitaire Vaudois

Lausanne, Canton of Vaud, Switzerland

Inselspital Bern Kinderklinik

Bern, , Switzerland

Hôpitaux Universitaires de Genève (HUG)

Geneva, , Switzerland

Universitaets-Kinderklinik - Kinderspital Zuerich

Zurich, , Switzerland

Brighton And Sussex University Hospitals NHS Trust

Brighton, East Sussex, United Kingdom

Royal Hospital for Children and Young People

Edinburgh, , United Kingdom

Royal London Hospital

London, , United Kingdom

King's College Hospital

London, , United Kingdom

Royal Manchester Children's Hospital - Paediatrics - Paediatrics

Manchester, , United Kingdom

Nottingham University Hospitals NHS Trust - Queen's Medical Centre

Nottingham, , United Kingdom

Countries

Germany; Hungary; Italy; Poland; Switzerland; United Kingdom

Other Identifiers

2024-511581-37-00

Identifier Type: CTIS

Identifier Source: secondary_id

BV-2020/08

Identifier Type: -

Identifier Source: org_study_id