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OM-85 bij terugkerende luchtweginfecties bij kinderen met piepende ademhaling Ziekte van de onderste luchtwegen

24 september 2026 bijgewerkt door: OM Pharma SA

Een gerandomiseerde, placebo-gecontroleerde, 3-armige, dubbelblinde, multicenter, fase 4-studie om de werkzaamheid te beoordelen van OM-85 (Broncho-Vaxom) korte- en langetermijnbehandeling vs. placebo bij de preventie van luchtweginfecties bij kinderen tussen 6 maanden en 5 jaar met piepende ademhaling

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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).

Studietype

Ingrijpend

Inschrijving (Werkelijk)

525

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Duitsland
    • Bavaria
      • München, Bavaria, Duitsland, 80337
        • Ludwig Maximilians Universität München
      • Schönau am Königssee, Bavaria, Duitsland, 83471
        • Clinical Research & Healthcare GmbH
    • Lower Saxony
      • Hanover, Lower Saxony, Duitsland, 30625
        • Medizinische Hochschule Hannover
    • North Rhine-Westphalia
      • Bochum, North Rhine-Westphalia, Duitsland, 44791
        • St. Josef-Hospital
      • Cologne, North Rhine-Westphalia, Duitsland, 50937
        • University Hospital Cologne AöR
      • Düsseldorf, North Rhine-Westphalia, Duitsland, 40217
        • Ev. Krankenhaus Düsseldorf
      • Mönchengladbach, North Rhine-Westphalia, Duitsland, 41236
        • Praxis Köllges
      • Wesel, North Rhine-Westphalia, Duitsland, 46483
        • Marien-Hospital Wesel gGmbH
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Duitsland, 23538
        • Universitätsklinikum Schleswig-Holstein Campus Lübeck
  • Hongarije
      • Balassagyarmat, Hongarije, H-2660
        • Dr. Kenessey Albert Korhaz-Rendelointezet
      • Budapest, Hongarije, 1089
        • Heim Pal Orszagos Gyermekgyogyaszati Intezet
      • Budapest, Hongarije, 1083
        • Semmelweis Egyetem I.sz. Gyermekgyogyaszati Klinika
      • Gyula, Hongarije, 5700
        • Sanitas Diagnosztikai és Rehabilitációs Központ
      • Miskolc, Hongarije, 3527
        • Futurenest Kft.
    • Csongrád megye
      • Szeged, Csongrád megye, Hongarije, 6720
        • Aranyklinika Kft
  • Italië
      • Bari, Italië, 70126
        • Osp.Pediatr.Giov.XXIII,AOUC P.Bari
      • Bergamo, Italië, 24127
        • ASST Papa GiovanniXXIII,Mat.Inf.Ped
    • Parma
      • Parma, Parma, Italië, 43100
        • Azienda ospedalo universitaria
    • Pavia
      • Pavia, Pavia, Italië, 27100
        • Universita degli Studi di Pavia - Fondazione IRCCS Policlini
    • Pisa
      • Pisa, Pisa, Italië, 56126
        • SO S.Chiara, AOU Pisana
  • Polen
      • Krakow, Polen, 31-411
        • Centrum Medyczne PROMED
      • Rzeszów, Polen, 35-612
        • Podkarpacki Osrodek Pulmonologii i Alergologii Sp. z o.o.
      • Skierniewice, Polen, 96-100
        • Velocity Skierniewice Sp. z o.o.
      • Warsaw, Polen, 01-231
        • Przychodnia Specjalistyczna Prosen-Med NZOZ
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polen, 31-624
        • Malopolskie Centrum Alergologii
      • Tarnów, Lesser Poland Voivodeship, Polen, 33-100
        • ALERGO-MED Specjalistyczna Przychodnia Lekarska Spolka z o.o.
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen, 20-552
        • Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
    • Lódzkie
      • Lodz, Lódzkie, Polen, 90-329
        • WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Polen, 15-879
        • NZOZ E-Vita
    • Silesian Voivodeship
      • Częstochowa, Silesian Voivodeship, Polen, 42-217
        • Centrum Medyczne Pratia Czestochowa
      • Siemianowice Śląskie, Silesian Voivodeship, Polen, 41-103
        • NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska
    • Świętokrzyskie Voivodeship
      • Skarżysko-Kamienna, Świętokrzyskie Voivodeship, Polen, 26-110
        • NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.
  • Verenigd Koninkrijk
      • Edinburgh, Verenigd Koninkrijk, EH9 1LF
        • Royal Hospital for Children and Young People
      • London, Verenigd Koninkrijk, SE5 9RS
        • King's College Hospital
      • London, Verenigd Koninkrijk, E1 4NS
        • Royal London Hospital
    • East Sussex
      • Brighton, East Sussex, Verenigd Koninkrijk, BN2 5BE
        • Brighton And Sussex University Hospitals NHS Trust
    • Manchester
      • Manchester, Manchester, Verenigd Koninkrijk, M13 9WL
        • Royal Manchester Children's Hospital - Paediatrics - Paediatrics
    • Nottingham
      • Nottingham, Nottingham, Verenigd Koninkrijk, NG7 2UH
        • Nottingham University Hospitals NHS Trust - Queen's Medical Centre
  • Zwitserland
      • Geneva, Zwitserland, 1205
        • Hôpitaux Universitaires de Genève (HUG)
      • Zurich, Zwitserland, 8032
        • Universitaets-Kinderklinik - Kinderspital Zuerich
    • Canton of Bern
      • Bern, Canton of Bern, Zwitserland, 3010
        • Inselspital Bern Kinderklinik
    • Canton of Vaud
      • Lausanne, Canton of Vaud, Zwitserland, 1011
        • CHUV-Centre Hopitalier Universitaire Vaudois

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

6 maanden tot 5 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: BV-12

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

Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month)
Experimenteel: BV-3

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

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

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

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of respiratory tract infections (RTIs)
Tijdsspanne: 12 Months

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject
Tijdsspanne: 12 Months

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
Tijdsspanne: 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.
18 Months
Rate of respiratory tract infections (RTIs)
Tijdsspanne: 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.
18 Months
Proportion of subjects with recurrent RTIs
Tijdsspanne: 18 Months

The proportion of subjects experiencing ≥3 RTIs during the first 6 months of Treatment period, the proportion of subjects experiencing ≥4 RTIs during the full 12-month Treatment period and the proportion of subjects experiencing ≥6 RTIs during the full 12-month Treatment period and during the whole study period will be assessed.
18 Months
Proportion of subjects with wLRIs
Tijdsspanne: 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.
18 Months
Rate of severe wheezing lower respiratory illness (SwLRIs)
Tijdsspanne: 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.
18 Months
Proportion of subjects with SwLRIs
Tijdsspanne: 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.
18 Months
Time to first, second and third RTI and wLRI
Tijdsspanne: 18 Months

Time to first, second and third RTI and wLRI during the whole study period will be assessed.
18 Months
Mean duration in days per RTI and acute RTI
Tijdsspanne: 18 Months

Mean duration in days per RTI and mean duration in days per acute RTI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 Months
Mean duration in days per wLRI
Tijdsspanne: 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.
18 Months
Mean duration in days per SwLRI
Tijdsspanne: 18 months

Mean duration in days per SwLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.
18 months
Number of healthcare resource utilisations
Tijdsspanne: 18 Months

Number of healthcare resource utilisations (inpatient 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.
18 Months
Number of absent days from daycare
Tijdsspanne: 18 Months

Number of absent days from daycare 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.
18 Months
Number of antibiotic treatments for a respiratory event
Tijdsspanne: 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.
18 Months
Duration of antibiotic treatments for a respiratory event
Tijdsspanne: 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.
18 Months
Number of systemic corticosteroids, inhaled corticosteroids (ICS) and β2-agonist treatments for a wLRI
Tijdsspanne: 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.
18 Months
Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI
Tijdsspanne: 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.
18 Months
Symptom duration as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire
Tijdsspanne: 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 Months
Symptom types as per the adapted WURSS-K questionnaire
Tijdsspanne: 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.
18 Months
Symptom severity as per the adapted WURSS-K questionnaire
Tijdsspanne: 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.
18 Months
Proportion of subjects who have not used antibiotics as rescue medication for RTI
Tijdsspanne: 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.
18 Months
Proportion of subjects who have not been hospitalised for an RTI
Tijdsspanne: 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.
18 Months
Proportion of subjects who have not been administered a systemic corticosteroid for wLRI
Tijdsspanne: 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.
18 Months
Proportion of subjects who have not been hospitalised for more than 1 day for wLRI
Tijdsspanne: 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.
18 Months

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of subjects with adverse events and serious adverse event
Tijdsspanne: 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.
18 Months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

OM Pharma SA

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 december 2022

Primaire voltooiing (Werkelijk)

10 maart 2026

Studie voltooiing (Werkelijk)

16 september 2026

Studieregistratiedata

Eerst ingediend

14 december 2022

Eerst ingediend dat voldeed aan de QC-criteria

22 december 2022

Eerst geplaatst (Werkelijk)

10 januari 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

25 september 2026

Laatste update ingediend die voldeed aan QC-criteria

24 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • BV-2020/08
  • 2024-511581-37-00 (Ctis)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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