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OM-85 lasten toistuvissa hengitystieinfektioissa, joihin liittyy hengityksen vinkuminen alahengityssairauksia

torstai 24. syyskuuta 2026 päivittänyt: OM Pharma SA

Satunnaistettu, lumekontrolloitu, 3-haarainen, kaksoissokkoutettu, monikeskustutkimus, vaihe 4, jolla arvioitiin OM-85:n (Broncho-Vaxom) lyhyt- ja pitkäaikaishoidon tehoa plaseboon verrattuna hengitystieinfektioiden ehkäisyssä 6 kuukauden ja 5 vuoden ikäisillä lapsilla, joilla on hengityksen vinkuminen alempien hengitysteiden sairaus

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.

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

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).

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

525

Vaihe

  • Vaihe 4

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

6 kuukautta - 5 vuotta (Lapsi)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: BV-12

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

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

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

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

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Rate of respiratory tract infections (RTIs)
Aikaikkuna: 12 Months

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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Muut tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of subjects with adverse events and serious adverse event
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

OM Pharma SA

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

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Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

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

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