OM-85 gyermekgyógyászati visszatérő légúti fertőzésekben sípoló alsó légúti betegségben
Randomizált, placebo-kontrollos, 3 karú, kettős vak, többközpontú, 4. fázisú vizsgálat az OM-85 (Broncho-Vaxom) rövid és hosszú távú kezelésének placebóval szembeni hatékonyságának felmérésére a légúti fertőzések megelőzésében 6 hónap és 5 év közötti, sípoló alsó légúti betegségben szenvedő gyermekeknél
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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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).
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- 4. fázis
Kapcsolatok és helyek
Tanulmányi helyek
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Edinburgh, Egyesült Királyság, EH9 1LF
- Royal Hospital for Children and Young People
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London, Egyesült Királyság, SE5 9RS
- King's College Hospital
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London, Egyesült Királyság, E1 4NS
- Royal London Hospital
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East Sussex
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Brighton, East Sussex, Egyesült Királyság, BN2 5BE
- Brighton And Sussex University Hospitals NHS Trust
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Manchester
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Manchester, Manchester, Egyesült Királyság, M13 9WL
- Royal Manchester Children's Hospital - Paediatrics - Paediatrics
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Nottingham
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Nottingham, Nottingham, Egyesült Királyság, NG7 2UH
- Nottingham University Hospitals NHS Trust - Queen's Medical Centre
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Krakow, Lengyelország, 31-411
- Centrum Medyczne PROMED
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Rzeszów, Lengyelország, 35-612
- Podkarpacki Osrodek Pulmonologii i Alergologii Sp. z o.o.
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Skierniewice, Lengyelország, 96-100
- Velocity Skierniewice Sp. z o.o.
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Warsaw, Lengyelország, 01-231
- Przychodnia Specjalistyczna Prosen-Med NZOZ
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Lesser Poland Voivodeship
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Krakow, Lesser Poland Voivodeship, Lengyelország, 31-624
- Malopolskie Centrum Alergologii
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Tarnów, Lesser Poland Voivodeship, Lengyelország, 33-100
- ALERGO-MED Specjalistyczna Przychodnia Lekarska Spolka z o.o.
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Lengyelország, 20-552
- Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna
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Lódzkie
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Lodz, Lódzkie, Lengyelország, 90-329
- WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Lengyelország, 15-879
- NZOZ E-Vita
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Silesian Voivodeship
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Częstochowa, Silesian Voivodeship, Lengyelország, 42-217
- Centrum Medyczne Pratia Czestochowa
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Siemianowice Śląskie, Silesian Voivodeship, Lengyelország, 41-103
- NZLA Michalkowice - Jarosz i Partnerzy Spolka Lekarska
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Świętokrzyskie Voivodeship
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Skarżysko-Kamienna, Świętokrzyskie Voivodeship, Lengyelország, 26-110
- NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J.
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Balassagyarmat, Magyarország, H-2660
- Dr. Kenessey Albert Korhaz-Rendelointezet
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Budapest, Magyarország, 1089
- Heim Pal Orszagos Gyermekgyogyaszati Intezet
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Budapest, Magyarország, 1083
- Semmelweis Egyetem I.sz. Gyermekgyogyaszati Klinika
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Gyula, Magyarország, 5700
- Sanitas Diagnosztikai és Rehabilitációs Központ
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Miskolc, Magyarország, 3527
- Futurenest Kft.
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Csongrád megye
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Szeged, Csongrád megye, Magyarország, 6720
- Aranyklinika Kft
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Bavaria
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München, Bavaria, Németország, 80337
- Ludwig Maximilians Universität München
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Schönau am Königssee, Bavaria, Németország, 83471
- Clinical Research & Healthcare GmbH
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Lower Saxony
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Hanover, Lower Saxony, Németország, 30625
- Medizinische Hochschule Hannover
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North Rhine-Westphalia
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Bochum, North Rhine-Westphalia, Németország, 44791
- St. Josef-Hospital
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Cologne, North Rhine-Westphalia, Németország, 50937
- University Hospital Cologne AöR
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Düsseldorf, North Rhine-Westphalia, Németország, 40217
- Ev. Krankenhaus Düsseldorf
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Mönchengladbach, North Rhine-Westphalia, Németország, 41236
- Praxis Köllges
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Wesel, North Rhine-Westphalia, Németország, 46483
- Marien-Hospital Wesel gGmbH
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Schleswig-Holstein
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Lübeck, Schleswig-Holstein, Németország, 23538
- Universitätsklinikum Schleswig-Holstein Campus Lübeck
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Bari, Olaszország, 70126
- Osp.Pediatr.Giov.XXIII,AOUC P.Bari
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Bergamo, Olaszország, 24127
- ASST Papa GiovanniXXIII,Mat.Inf.Ped
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Parma
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Parma, Parma, Olaszország, 43100
- Azienda ospedalo universitaria
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Pavia
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Pavia, Pavia, Olaszország, 27100
- Universita degli Studi di Pavia - Fondazione IRCCS Policlini
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Pisa
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Pisa, Pisa, Olaszország, 56126
- SO S.Chiara, AOU Pisana
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Geneva, Svájc, 1205
- Hôpitaux Universitaires de Genève (HUG)
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Zurich, Svájc, 8032
- Universitaets-Kinderklinik - Kinderspital Zuerich
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Canton of Bern
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Bern, Canton of Bern, Svájc, 3010
- Inselspital Bern Kinderklinik
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Canton of Vaud
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Lausanne, Canton of Vaud, Svájc, 1011
- CHUV-Centre Hopitalier Universitaire Vaudois
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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:
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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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: BV-12
Subjects will receive OM-85 treatment for 12 consecutive months. (10 days per month) |
Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month) |
|
Kísérleti: BV-3
Subjects will receive OM-85 treatment for 3 consecutive months, followed by matching placebo for 9 consecutive months. (10 days per month) |
Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month) |
|
Placebo Comparator: Placebo
Subjects will receive matching placebo for 12 consecutive months. (10 days per month) |
Subjects will be administered Placebo once daily. (10 days per month) |
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Rate of respiratory tract infections (RTIs)
Időkeret: 12 Months
|
The number of RTIs experienced by a subject during the Treatment period will be assessed. |
12 Months
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject
Időkeret: 12 Months
|
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
Időkeret: 18 Months
|
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)
Időkeret: 18 Months
|
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
Időkeret: 18 Months
|
The proportion of subjects experiencing ≥3 RTIs during the first 6 months of Treatment period, the proportion of subjects experiencing ≥4 RTIs during the full 12-month Treatment period and the proportion of subjects experiencing ≥6 RTIs during the full 12-month Treatment period and during the whole study period will be assessed. |
18 Months
|
|
Proportion of subjects with wLRIs
Időkeret: 18 Months
|
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)
Időkeret: 18 Months
|
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
|
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Proportion of subjects with SwLRIs
Időkeret: 18 Months
|
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
Időkeret: 18 Months
|
Time to first, second and third RTI and wLRI during the whole study period will be assessed. |
18 Months
|
|
Mean duration in days per RTI and acute RTI
Időkeret: 18 Months
|
Mean duration in days per RTI and mean duration in days per acute RTI during the Treatment period, during the Observational period, and during the whole study period will be assessed. |
18 Months
|
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Mean duration in days per wLRI
Időkeret: 18 Months
|
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
|
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Mean duration in days per SwLRI
Időkeret: 18 months
|
Mean duration in days per SwLRI during the Treatment period, during the Observational period, and during the whole study period will be assessed. |
18 months
|
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Number of healthcare resource utilisations
Időkeret: 18 Months
|
Number of healthcare resource utilisations (inpatient 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 daycare
Időkeret: 18 Months
|
Number of absent days from daycare 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
Időkeret: 18 Months
|
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
|
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Duration of antibiotic treatments for a respiratory event
Időkeret: 18 Months
|
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
Időkeret: 18 Months
|
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
Időkeret: 18 Months
|
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
Időkeret: 18 Months
|
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
Időkeret: 18 Months
|
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
Időkeret: 18 Months
|
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
Időkeret: 18 Months
|
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
Időkeret: 18 Months
|
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
Időkeret: 18 Months
|
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
Időkeret: 18 Months
|
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
|
Egyéb eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Number of subjects with adverse events and serious adverse event
Időkeret: 18 Months
|
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
|
Együttműködők és nyomozók
Szponzor
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- BV-2020/08
- 2024-511581-37-00 (Ctis)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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