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ACTIVE NOT RECRUITING

NCT05677763

PHASE4

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

Sponsor: OM Pharma SA

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

6 Months - 5 Years

Study Type

INTERVENTIONAL

Enrollment

525

Start Date

2022-12-12

Completion Date

2026-09-16

Last Updated

2026-03-24

Healthy Volunteers

Conditions

Respiratory Tract Infections Wheezing Lower Respiratory Illness

Interventions

DRUG

OM-85

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

DRUG

Placebo

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

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.

Locations (42)

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

Azienda ospedalo universitaria

Parma, Parma, Italy

Universita degli Studi di Pavia - Fondazione IRCCS Policlini

Pavia, Pavia, Italy

SO S.Chiara, AOU Pisana

Pisa, Pisa, Italy

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

Bari, Italy

ASST Papa GiovanniXXIII,Mat.Inf.Ped

Bergamo, 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

Inselspital Bern Kinderklinik

Bern, Canton of Bern, Switzerland

CHUV-Centre Hopitalier Universitaire Vaudois

Lausanne, Canton of Vaud, 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 Manchester Children's Hospital - Paediatrics - Paediatrics

Manchester, Manchester, United Kingdom

Nottingham University Hospitals NHS Trust - Queen's Medical Centre

Nottingham, Nottingham, United Kingdom

Royal Hospital for Children and Young People

Edinburgh, United Kingdom

Royal London Hospital

London, United Kingdom

King's College Hospital