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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-511581-37-00 | EU Trial (CTIS) Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BV-12 | Experimental | Subjects will receive OM-85 treatment for 12 consecutive months. (10 days per month) |
|
| BV-3 | Experimental | Subjects will receive OM-85 treatment for 3 consecutive months, followed by matching placebo for 9 consecutive months. (10 days per month) |
|
| Placebo | Placebo Comparator | Subjects will receive matching placebo for 12 consecutive months. (10 days per month) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OM-85 | Drug | Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of respiratory tract infections (RTIs) | The number of RTIs experienced by a subject during the Treatment period will be assessed. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Rate of wLRIs |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
OR
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:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwig Maximilians Universität München | München | Bavaria | 80337 | Germany | ||
| Clinical Research & Healthcare GmbH |
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| Placebo | Drug | Subjects will be administered Placebo once daily. (10 days per month) |
|
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) | 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 | 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 |
| 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. | 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. | 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. | 18 Months |
| Time to first, second and third RTI and wLRI | Time to first, second and third RTI and wLRI will be assessed. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 18 Months |
| Schönau am Königssee |
| Bavaria |
| 83471 |
| Germany |
| Medizinische Hochschule Hannover | Hanover | Lower Saxony | 30625 | Germany |
| St. Josef-Hospital | Bochum | North Rhine-Westphalia | 44791 | Germany |
| University Hospital Cologne AöR | Cologne | North Rhine-Westphalia | 50937 | Germany |
| Ev. Krankenhaus Düsseldorf | Düsseldorf | North Rhine-Westphalia | 40217 | Germany |
| Praxis Köllges | Mönchengladbach | North Rhine-Westphalia | 41236 | Germany |
| Marien-Hospital Wesel gGmbH | Wesel | North Rhine-Westphalia | 46483 | Germany |
| Universitätsklinikum Schleswig-Holstein Campus Lübeck | Lübeck | Schleswig-Holstein | 23538 | Germany |
| Aranyklinika Kft | Szeged | Csongrád megye | 6720 | Hungary |
| Dr. Kenessey Albert Korhaz-Rendelointezet | Balassagyarmat | H-2660 | Hungary |
| Semmelweis Egyetem I.sz. Gyermekgyogyaszati Klinika | Budapest | 1083 | Hungary |
| Heim Pal Orszagos Gyermekgyogyaszati Intezet | Budapest | 1089 | Hungary |
| Sanitas Diagnosztikai és Rehabilitációs Központ | Gyula | 5700 | Hungary |
| Futurenest Kft. | Miskolc | 3527 | Hungary |
| Azienda ospedalo universitaria | Parma | Parma | 43100 | Italy |
| Universita degli Studi di Pavia - Fondazione IRCCS Policlini | Pavia | Pavia | 27100 | Italy |
| SO S.Chiara, AOU Pisana | Pisa | Pisa | 56126 | Italy |
| Osp.Pediatr.Giov.XXIII,AOUC P.Bari | Bari | 70126 | Italy |
| ASST Papa GiovanniXXIII,Mat.Inf.Ped | Bergamo | 24127 | Italy |
| Malopolskie Centrum Alergologii | Krakow | Lesser Poland Voivodeship | 31-624 | Poland |
| ALERGO-MED Specjalistyczna Przychodnia Lekarska Spolka z o.o. | Tarnów | Lesser Poland Voivodeship | 33-100 | Poland |
| Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna | Lublin | Lublin Voivodeship | 20-552 | Poland |
| WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka | Lodz | Lódzkie | 90-329 | Poland |
| NZOZ E-Vita | Bialystok | Podlaskie Voivodeship | 15-879 | Poland |
| Centrum Medyczne Pratia Czestochowa | Częstochowa | Silesian Voivodeship | 42-217 | Poland |
| NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska | Siemianowice Śląskie | Silesian Voivodeship | 41-103 | Poland |
| Centrum Medyczne PROMED | Krakow | 31-411 | Poland |
| Podkarpacki Osrodek Pulmonologii i Alergologii Sp. z o.o. | Rzeszów | 35-612 | Poland |
| Velocity Skierniewice Sp. z o.o. | Skierniewice | 96-100 | Poland |
| Przychodnia Specjalistyczna Prosen-Med NZOZ | Warsaw | 01-231 | Poland |
| NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J. | Skarżysko-Kamienna | Świętokrzyskie Voivodeship | 26-110 | Poland |
| Inselspital Bern Kinderklinik | Bern | Canton of Bern | 3010 | Switzerland |
| CHUV-Centre Hopitalier Universitaire Vaudois | Lausanne | Canton of Vaud | 1011 | Switzerland |
| Hôpitaux Universitaires de Genève (HUG) | Geneva | 1205 | Switzerland |
| Universitaets-Kinderklinik - Kinderspital Zuerich | Zurich | 8032 | Switzerland |
| Brighton And Sussex University Hospitals NHS Trust | Brighton | East Sussex | BN2 5BE | United Kingdom |
| Royal Manchester Children's Hospital - Paediatrics - Paediatrics | Manchester | Manchester | M13 9WL | United Kingdom |
| Nottingham University Hospitals NHS Trust - Queen's Medical Centre | Nottingham | Nottingham | NG7 2UH | United Kingdom |
| Royal Hospital for Children and Young People | Edinburgh | EH9 1LF | United Kingdom |
| Royal London Hospital | London | E1 4NS | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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