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

Phase 4Active Not RecruitingNCT05677763

OM Pharma SA525 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

525

Conditions

Respiratory Tract Infections Wheezing Lower Respiratory Illness

Interventions

OM-85DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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.

Locations (42)

Outcomes

Primary Outcomes

Rate of respiratory tract infections (RTIs)

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

Time frame: 12 Months

Secondary Outcomes

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

Time frame: 12 Months

Rate of wLRIs

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.

Time frame: 18 Months

Rate of respiratory tract infections (RTIs)

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.

Time frame: 18 Months

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.

Time frame: 12 Months

Proportion of subjects with wLRIs

The proportion of subjects with wLRIs during the Treatment period, during the Observational period, and during the whole study period will be assessed.

Time frame: 18 Months

Rate of severe wheezing lower respiratory illness (SwLRIs)

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.

Data from ClinicalTrials.gov

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Ludwig Maximilians Universität München

München, Bavaria, Germany

Clinical Research & Healthcare GmbH

Schönau am Königssee, Bavaria, Germany

Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

St. Josef-Hospital

Bochum, North Rhine-Westphalia, Germany

University Hospital Cologne AöR

Cologne, North Rhine-Westphalia, Germany

Ev. Krankenhaus Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Praxis Köllges

Mönchengladbach, North Rhine-Westphalia, Germany

Marien-Hospital Wesel gGmbH

Wesel, North Rhine-Westphalia, Germany

Universitätsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, Schleswig-Holstein, Germany

Aranyklinika Kft

Szeged, Csongrád megye, Hungary

...and 32 more locations

Time frame: 18 Months

Proportion of subjects with SwLRIs

The proportion of subjects with SwLRIs during the Treatment period, during the Observational period, and during the whole study period will be assessed.

Time frame: 18 Months

Time to first, second and third RTI and wLRI

Time to first, second and third RTI and wLRI will be assessed.

Time frame: 18 Months

Mean duration in days per RTI

Mean duration in days per RTI during the Treatment period, during the Observational period, and during the whole study period will be assessed.

Time frame: 18 Months

Mean duration in days per wLRI

Mean duration in days per wLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed.

Time frame: 18 Months

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, during the Observational period, and during the whole study period will be assessed.

Time frame: 18 Months

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, during the Observational period, and during the whole study period will be assessed.

Time frame: 18 Months

Number of antibiotic treatments for a respiratory event

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.

Time frame: 18 Months

Duration of antibiotic treatments for a respiratory event

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.

Time frame: 18 Months

Number of systemic corticosteroids, inhaled corticosteroids (ICS) and β2-agonist treatments for a wLRI

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.

Time frame: 18 Months

Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI

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.

Time frame: 18 Months

Symptom duration as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire

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.

Time frame: 18 Months

Symptom types as per the adapted WURSS-K questionnaire

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.

Time frame: 18 Months

Symptom severity as per the adapted WURSS-K questionnaire

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.

Time frame: 18 Months

Proportion of subjects who have not used antibiotics as rescue medication for RTI

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.

Time frame: 18 Months

Proportion of subjects who have not been hospitalised for an RTI

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.

Time frame: 18 Months

Proportion of subjects who have not been administered a systemic corticosteroid for wLRI

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.

Time frame: 18 Months

Proportion of subjects who have not been hospitalised for more than 1 day for wLRI

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.

Time frame: 18 Months