OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness
- Conditions
- Wheezing Lower Respiratory IllnessRespiratory Tract Infections
- Interventions
- Drug: Placebo
- Registration Number
- NCT05677763
- Lead Sponsor
- OM Pharma SA
- 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)
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 525
- 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.
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Anatomic alterations of the respiratory tract.
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Other chronic respiratory diseases (e.g., tuberculosis, cystic fibrosis).
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Any autoimmune disease.
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HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).
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Known severe congenital heart disease.
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Haematologic diseases.
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Liver or kidney failure.
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New-borns before 34 weeks of gestational age.
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Malnutrition as per World Health Organization (WHO) definition.
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Any known neoplasia or malignancy.
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Treatment with the following medications:
- Injection or oral administration of steroids within 4 weeks prior to study enrolment.
- Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to study enrolment.
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Previous use within last 6 months of enrolment or ongoing use of bacterial lysates.
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Any major surgery within the last 3 months prior to study enrolment.
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Known allergy or previous intolerance to investigational medicinal products (IMP).
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Any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study.
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Other household members have previously been randomised in this clinical study.
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Subjects' families expected to relocate out of study area within 24 months of the initiation of the study.
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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.
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Parents or legally acceptable representative (LAR) who do not have access to internet connection.
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Wheezing documented to be caused by gastroesophageal reflux.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BV-3 OM-85 Subjects will receive OM-85 treatment for 3 consecutive months, followed by matching placebo for 9 consecutive months. (10 days per month) Placebo Placebo Subjects will receive matching placebo for 12 consecutive months. (10 days per month) BV-12 OM-85 Subjects will receive OM-85 treatment for 12 consecutive months. (10 days per month)
- Primary Outcome Measures
Name Time Method Rate of respiratory tract infections (RTIs) 12 Months The number of RTIs experienced by a subject during the Treatment period will be assessed.
- Secondary Outcome Measures
Name Time Method Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject 12 Months The number of wLRIs experienced by a subject during the Treatment period will be assessed. This is the key secondary endpoint
Rate of wLRIs 18 Months The number of wLRIs experienced by a subject during the Treatment period and during the Observational period will be assessed.
Rate of respiratory tract infections (RTIs) 18 Months The number of RTIs experienced by a subject during the Treatment period and during the Observational period will be assessed.
Proportion of subjects with recurrent RTIs 12 Months 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.
Proportion of subjects with wLRIs 18 Months The proportion of subjects with wLRIs during the Treatment period and during the Observational period will be assessed.
Rate of severe wheezing lower respiratory illness (SwLRIs) 18 Months The number of SwLRIs experienced by a subject during the Treatment period and during the Observational period will be assessed.
Proportion of subjects with SwLRIs 18 Months The proportion of subjects with SwLRIs during the Treatment period and during the Observational period will be assessed.
Time to first, second and third RTI and wLRI 18 Months Time to first, second and third RTI and wLRI will be assessed.
Mean duration in days per wLRI 18 Months Mean duration in days per wLRI during the Treatment period and during the Observational period will be assessed.
Number of outpatient medical visits 18 Months 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.
Number of absent days from day-care 18 Months 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.
Number of antibiotic treatments for a respiratory event 18 Months Number of antibiotic treatments for a respiratory event during the Treatment period and during the Observational period will be assessed.
Number of systemic corticosteroids, inhaled corticosteroids (ICS) and β2-agonist treatments for a wLRI 18 Months Number of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI during the Treatment period and during the Observational period will be assessed.
Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI 18 Months Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI during the Treatment period and during the Observational period will be assessed.
Duration of antibiotic treatments for a respiratory event 18 Months Duration of antibiotic treatments for a respiratory event during the Treatment period and during the Observational period will be assessed.
Symptom duration as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire 18 Months 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.
Symptom types as per the adapted WURSS-K questionnaire 18 Months 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.
Symptom severity as per the adapted WURSS-K questionnaire 18 Months 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.
Mean duration in days per RTI 18 Months Mean duration in days per RTI during the Treatment period and during the Observational period will be assessed.
Trial Locations
- Locations (40)
Royal London Hospital
🇬🇧London, United Kingdom
Ludwig Maximilians Universität München
🇩🇪München, Bayern, Germany
Clinical Research & Healthcare GmbH
🇩🇪Schönau Am Königssee, Bayern, Germany
Medizinische Hochschule Hannover
🇩🇪Hanover, Niedersachsen, Germany
St. Josef-Hospital
🇩🇪Bochum, Nordrhein-Westfalen, Germany
University Hospital Cologne AöR
🇩🇪Cologne, Nordrhein-Westfalen, Germany
Ev. Krankenhaus Düsseldorf
🇩🇪Düsseldorf, North Rhine-Westphalia, Germany
Praxis Köllges
🇩🇪Moenchengladbach, 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, Hungary
Dr. Kenessey Albert Korhaz-Rendelointezet
🇭🇺Balassagyarmat, Hungary
Semmelweis Egyetem I.sz. Gyermekgyogyaszati Klinika
🇭🇺Budapest, Hungary
Heim Pal Orszagos Gyermekgyogyaszati Intezet
🇭🇺Budapest, Hungary
Sanitas Diagnosztikai és Rehabilitációs Központ
🇭🇺Gyula, Hungary
Futurenest Kft.
🇭🇺Miskolc, Hungary
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
SO S.Chiara, AOU Pisana
🇮🇹Pisa, Italy
Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
🇵🇱Lublin, Lubelskie, Poland
WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka
🇵🇱Łódź, Lódzkie, Poland
Malopolskie Centrum Alergologii
🇵🇱Krakow, Malopolskie, Poland
ALERGO-MED Specjalistyczna Przychodnia Lekarska Spolka z o.o.
🇵🇱Tarnów, Malopolskie, Poland
NZOZ E-Vita
🇵🇱Bialystok, Podlaskie, Poland
Centrum Medyczne Pratia Czestochowa
🇵🇱Czestochowa, Slaskie, Poland
NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska
🇵🇱Siemianowice Śląskie, Slaskie, Poland
NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.
🇵🇱Skarżysko-Kamienna, Swietokrzyskie, Poland
Centrum Medyczne PROMED
🇵🇱Kraków, Poland
Velocity Skierniewice Sp. z o.o.
🇵🇱Skierniewice, Poland
Przychodnia Specjalistyczna Prosen-Med NZOZ
🇵🇱Warszawa, Poland
CHUV-Centre Hopitalier Universitaire Vaudois
🇨🇭Lausanne, Vaud, Switzerland
Inselspital Bern Kinderklinik
🇨🇭Bern, Switzerland
Hôpitaux Universitaires de Genève (HUG)
🇨🇭Geneva, Switzerland
Universitaets-Kinderklinik - Kinderspital Zuerich
🇨🇭Zuerich, Switzerland
Brighton And Sussex University Hospitals NHS Trust
🇬🇧Brighton, East Sussex, United Kingdom
Royal Hospital for Children and Young People
🇬🇧Edinburgh, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
Royal Manchester Children's Hospital - Paediatrics - Paediatrics
🇬🇧Manchester, United Kingdom