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喘鳴を伴う小児再発性気道感染症におけるOM-85 下部呼吸器疾患

2026年9月24日 更新者：OM Pharma SA

気道感染症の予防におけるOM-85（Broncho-Vaxom）の短期および長期治療とプラセボの有効性を評価するための無作為化、プラセボ対照、3アーム、二重盲検、多施設共同、第4相試験喘鳴を伴う生後6か月から5歳までの小児の下​​部呼吸器疾患

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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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).

研究の種類

介入

入学 (実際)

525

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

6ヶ月～5年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：BV-12

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

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

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

Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month)
プラセボコンパレーター：Placebo

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

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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Rate of respiratory tract infections (RTIs)
時間枠：12 Months

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

二次結果の測定

結果測定
メジャーの説明
時間枠
Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

その他の成果指標

結果測定
メジャーの説明
時間枠
Number of subjects with adverse events and serious adverse event
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

OM Pharma SA

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2022年12月12日

一次修了 (実際)

2026年3月10日

研究の完了 (実際)

2026年9月16日

試験登録日

最初に提出

2022年12月14日

QC基準を満たした最初の提出物

2022年12月22日

最初の投稿 (実際)

2023年1月10日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月25日

QC基準を満たした最後の更新が送信されました

2026年9月24日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

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

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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