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OM-85 при педиатрических рецидивирующих инфекциях дыхательных путей с хрипящим заболеванием нижних дыхательных путей

24 сентября 2026 г. обновлено: OM Pharma SA

Рандомизированное, плацебо-контролируемое, двойное слепое, многоцентровое исследование фазы 4 с тремя группами для оценки эффективности краткосрочного и долгосрочного лечения ОМ-85 (Бронхо-Ваксом) по сравнению с плацебо в профилактике инфекций дыхательных путей у детей в возрасте от 6 месяцев до 5 лет с хрипящим заболеванием нижних дыхательных путей

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.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

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).

Тип исследования

Интервенционный

Регистрация (Действительный)

525

Фаза

  • Фаза 4

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 6 месяцев до 5 лет (Ребенок)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: BV-12

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

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

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

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

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

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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Rate of respiratory tract infections (RTIs)
Временное ограничение: 12 Months

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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Number of subjects with adverse events and serious adverse event
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

OM Pharma SA

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

12 декабря 2022 г.

Первичное завершение (Действительный)

10 марта 2026 г.

Завершение исследования (Действительный)

16 сентября 2026 г.

Даты регистрации исследования

Первый отправленный

14 декабря 2022 г.

Впервые представлено, что соответствует критериям контроля качества

22 декабря 2022 г.

Первый опубликованный (Действительный)

10 января 2023 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

25 сентября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

24 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

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

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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