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

Respiratory Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05677763
• Other study ID #: BV-2020/08
• Secondary ID: 2022-000886-42
• Status: Recruiting
• Phase: Phase 4
• Start date: December 12, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: OM Pharma SA
• Contact: Lorenz Lehr
• Phone: +41 22 783 14 59
• Email: lorenz.lehr[@]ompharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

A total of 426 subjects will be randomised in the study.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 426
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Sounds
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
Germany	St. Josef-Hospital	Bochum	Nordrhein-Westfalen
Germany	University Hospital Cologne AöR	Cologne	Nordrhein-Westfalen
Germany	Ev. Krankenhaus Düsseldorf	Düsseldorf	North Rhine-Westphalia
Germany	Medizinische Hochschule Hannover	Hanover	Niedersachsen
Germany	Universitätsklinikum Schleswig-Holstein Campus Lübeck	Lübeck	Schleswig-Holstein
Germany	Praxis Köllges	Moenchengladbach	North Rhine-Westphalia
Germany	Ludwig Maximilians Universität München	München	Bayern
Germany	Praxiszentrum Triftplatz - Pediatrics	Schönau Am Königssee	Bayern
Germany	Marien-Hospital Wesel gGmbH	Wesel	North Rhine-Westphalia
Hungary	Dr. Kenessey Albert Korhaz-Rendelointezet	Balassagyarmat
Hungary	Heim Pal Children's Hospital	Budapest
Hungary	Semmelweis University Faculty of Medicine I. Pediatric Clinic	Budapest
Hungary	Sanitas Diagnosztikai és Rehabilitációs Központ	Gyula
Hungary	Futurenest Kft.	Miskolc
Hungary	Aranyklinika Kft	Szeged	Csongrád
Italy	Osp.Pediatr.Giov.XXIII,AOUC P.Bari	Bari
Italy	ASST Papa GiovanniXXIII,Mat.Inf.Ped	Bergamo
Italy	Azienda ospedalo universitaria	Parma
Italy	Universita degli Studi di Pavia - Fondazione IRCCS Policlini	Pavia
Italy	University of Pisa	Pisa
Poland	NZOZ E-Vita	Bialystok	Podlaskie
Poland	Centrum Medyczne PROMED	Kraków
Poland	WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka	Lódz	Lódzkie
Poland	Instytut Gruzlicy i Chorob Pluc Oddzial Terenowy	Rabka-Zdrój
Poland	NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska	Siemianowice Slaskie	Slaskie
Poland	NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.	Skarzysko-Kamienna	Swietokrzyskie
Poland	ETG Skierniewice	Skierniewice
Poland	ALERGO-MED Specjalistyczna Przychodnia Lekarska Spolka z o.o.	Tarnów	Malopolskie
Poland	Przychodnia Specjalistyczna Prosen-Med NZOZ	Warszawa
Switzerland	Inselspital Bern Kinderklinik	Bern	Bern (de)
Switzerland	Hôpitaux Universitaires de Genève (HUG)	Geneva
Switzerland	CHUV-Centre Hopitalier Universitaire Vaudois	Lausanne	Vaud (fr)
Switzerland	Universitaets-Kinderklinik - Kinderspital Zuerich	Zuerich
United Kingdom	Brighton And Sussex University Hospitals NHS Trust	Brighton	East Sussex
United Kingdom	Royal Hospital for Children and Young People	Edinburgh
United Kingdom	University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	King's College Hospital	London
United Kingdom	Royal London Hospital	London
United Kingdom	Royal Manchester Children's Hospital - Paediatrics - Paediatrics	Manchester
United Kingdom	Nottingham University Hospitals NHS Trust - Queen's Medical Centre	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
OM Pharma SA

Countries where clinical trial is conducted

Germany,  Hungary,  Italy,  Poland,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of subjects with adverse events and serious adverse event	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
Primary	Rate of respiratory tract infections (RTIs)	The number of RTIs experienced by a subject during the Treatment period will be assessed.	12 Months
Secondary	Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject	The number of wLRIs experienced by a subject during the Treatment period will be assessed. This is the key secondary endpoint	12 Months
Secondary	Rate of wLRIs	The number of wLRIs experienced by a subject during the Treatment period and during the Observational period will be assessed.	18 Months
Secondary	Rate of respiratory tract infections (RTIs)	The number of RTIs experienced by a subject during the Treatment period and during the Observational period will be assessed.	18 Months
Secondary	Proportion of subjects with recurrent RTIs	The proportion of subjects experiencing =3 RTIs during the first 6 months of treatment, and the number of subjects experiencing =4 RTIs during the full 12-month Treatment period will be assessed.	12 Months
Secondary	Proportion of subjects with wLRIs	The proportion of subjects with wLRIs during the Treatment period and during the Observational period will be assessed.	18 Months
Secondary	Rate of severe wheezing lower respiratory illness (SwLRIs)	The number of SwLRIs experienced by a subject during the Treatment period and during the Observational period will be assessed.	18 Months
Secondary	Proportion of subjects with SwLRIs	The proportion of subjects with SwLRIs during the Treatment period and during the Observational period will be assessed.	18 Months
Secondary	Time to first, second and third RTI and wLRI	Time to first, second and third RTI and wLRI will be assessed.	18 Months
Secondary	Mean duration in days per RTI	Mean duration in days per RTI during the Treatment period and during the Observational period will be assessed.	18 Months
Secondary	Mean duration in days per wLRI	Mean duration in days per wLRI during the Treatment period and during the Observational period will be assessed.	18 Months
Secondary	Number of outpatient medical visits	Number of outpatient medical visits (hospitalisations, visits to emergency rooms, or to a physician/health care provider) due to an RTI and/or a wLRI during the Treatment period and during the Observational period will be assessed.	18 Months
Secondary	Number of absent days from day-care	Number of absent days from day-care due to an RTI and/or a wLRI during the Treatment period and during the Observational period will be assessed.	18 Months
Secondary	Number of antibiotic treatments for a respiratory event	Number of antibiotic treatments for a respiratory event during the Treatment period and during the Observational period will be assessed.	18 Months
Secondary	Duration of antibiotic treatments for a respiratory event	Duration of antibiotic treatments for a respiratory event during the Treatment period and during the Observational period will be assessed.	18 Months
Secondary	Number of systemic corticosteroids, inhaled corticosteroids (ICS) and ß2-agonist treatments for a wLRI	Number of systemic corticosteroids, ICS and ß2-agonist treatments for a wLRI during the Treatment period and during the Observational period will be assessed.	18 Months
Secondary	Duration of systemic corticosteroids, ICS and ß2-agonist treatments for a wLRI	Duration of systemic corticosteroids, ICS and ß2-agonist treatments for a wLRI during the Treatment period and during the Observational period will be assessed.	18 Months
Secondary	Symptom duration as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire	Symptom duration during the Treatment period and during the Observational 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
Secondary	Symptom types as per the adapted WURSS-K questionnaire	Symptom types during the Treatment period and during the Observational 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
Secondary	Symptom severity as per the adapted WURSS-K questionnaire	Symptom severity during the Treatment period and during the Observational 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