Clinical trial NCT05677763: OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Respiratory Tract Infections
Wheezing Lower Respiratory Illness
Lead sponsor: OM Pharma SA
Sponsor class: INDUSTRY
First posted: 2023-01-10
Enrollment: 525
Sex: ALL
Minimum age (years): 6
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of respiratory tract infections (RTIs)
timeFrame: 12 Months
Secondary outcomes:
measure: Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject
timeFrame: 12 Months
measure: Rate of wLRIs
timeFrame: 18 Months
measure: Rate of respiratory tract infections (RTIs)
timeFrame: 18 Months
measure: Proportion of subjects with recurrent RTIs
timeFrame: 12 Months
measure: Proportion of subjects with wLRIs
timeFrame: 18 Months
measure: Rate of severe wheezing lower respiratory illness (SwLRIs)
timeFrame: 18 Months
measure: Proportion of subjects with SwLRIs
timeFrame: 18 Months
measure: Time to first, second and third RTI and wLRI
timeFrame: 18 Months
measure: Mean duration in days per RTI
timeFrame: 18 Months
measure: Mean duration in days per wLRI
timeFrame: 18 Months
measure: Number of outpatient medical visits
timeFrame: 18 Months
measure: Number of absent days from day-care
timeFrame: 18 Months
measure: Number of antibiotic treatments for a respiratory event
timeFrame: 18 Months
measure: Duration of antibiotic treatments for a respiratory event
timeFrame: 18 Months
measure: Number of systemic corticosteroids, inhaled corticosteroids (ICS) and β2-agonist treatments for a wLRI
timeFrame: 18 Months
measure: Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI
timeFrame: 18 Months
measure: Symptom duration as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire
timeFrame: 18 Months
measure: Symptom types as per the adapted WURSS-K questionnaire
timeFrame: 18 Months
measure: Symptom severity as per the adapted WURSS-K questionnaire
timeFrame: 18 Months
Other outcomes:
measure: Number of subjects with adverse events and serious adverse event
timeFrame: 18 Months
Locations:
city: München
country: Germany
facility: Ludwig Maximilians Universität München
state: Bayern
city: Schönau Am Königssee
country: Germany
facility: Clinical Research & Healthcare GmbH
state: Bayern
city: Hanover
country: Germany
facility: Medizinische Hochschule Hannover
state: Niedersachsen
city: Bochum
country: Germany
facility: St. Josef-Hospital
state: Nordrhein-Westfalen
city: Cologne
country: Germany
facility: University Hospital Cologne AöR
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
facility: Ev. Krankenhaus Düsseldorf
state: North Rhine-Westphalia
city: Moenchengladbach
country: Germany
facility: Praxis Köllges
state: North Rhine-Westphalia
city: Wesel
country: Germany
facility: Marien-Hospital Wesel gGmbH
state: North Rhine-Westphalia
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck
state: Schleswig-Holstein
city: Szeged
country: Hungary
facility: Aranyklinika Kft
state: Csongrád
city: Balassagyarmat
country: Hungary
facility: Dr. Kenessey Albert Korhaz-Rendelointezet
city: Budapest
country: Hungary
facility: Semmelweis Egyetem I.sz. Gyermekgyogyaszati Klinika
city: Budapest
country: Hungary
facility: Heim Pal Orszagos Gyermekgyogyaszati Intezet
city: Gyula
country: Hungary
facility: Sanitas Diagnosztikai és Rehabilitációs Központ
city: Miskolc
country: Hungary
facility: Futurenest Kft.
city: Bari
country: Italy
facility: Osp.Pediatr.Giov.XXIII,AOUC P.Bari
city: Bergamo
country: Italy
facility: ASST Papa GiovanniXXIII,Mat.Inf.Ped
city: Parma
country: Italy
facility: Azienda ospedalo universitaria
city: Pavia
country: Italy
facility: Universita degli Studi di Pavia - Fondazione IRCCS Policlini
city: Pisa
country: Italy
facility: SO S.Chiara, AOU Pisana
city: Lublin
country: Poland
facility: Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
state: Lubelskie
city: Łódź
country: Poland
facility: WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka
state: Lódzkie
city: Krakow
country: Poland
facility: Malopolskie Centrum Alergologii
state: Malopolskie
city: Tarnów
country: Poland
facility: ALERGO-MED Specjalistyczna Przychodnia Lekarska Spolka z o.o.
state: Malopolskie
city: Bialystok
country: Poland
facility: NZOZ E-Vita
state: Podlaskie
city: Czestochowa
country: Poland
facility: Centrum Medyczne Pratia Czestochowa
state: Slaskie
city: Siemianowice Śląskie
country: Poland
facility: NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska
state: Slaskie
city: Skarżysko-Kamienna
country: Poland
facility: NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.
state: Swietokrzyskie
city: Kraków
country: Poland
facility: Centrum Medyczne PROMED
city: Skierniewice
country: Poland
facility: Velocity Skierniewice Sp. z o.o.
city: Warszawa
country: Poland
facility: Przychodnia Specjalistyczna Prosen-Med NZOZ
city: Lausanne
country: Switzerland
facility: CHUV-Centre Hopitalier Universitaire Vaudois
state: Vaud
city: Bern
country: Switzerland
facility: Inselspital Bern Kinderklinik
city: Geneva
country: Switzerland
facility: Hôpitaux Universitaires de Genève (HUG)
city: Zuerich
country: Switzerland
facility: Universitaets-Kinderklinik - Kinderspital Zuerich
city: Brighton
country: United Kingdom
facility: Brighton And Sussex University Hospitals NHS Trust
state: East Sussex
city: Edinburgh
country: United Kingdom
facility: Royal Hospital for Children and Young People
city: London
country: United Kingdom
facility: Royal London Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: Manchester
country: United Kingdom
facility: Royal Manchester Children's Hospital - Paediatrics - Paediatrics
Study officials:
References: