OM-85 in recurrent respiratory infections in children with wheezing lower respiratory tract diseases
Descrizione riassuntiva dello studio
The medication being studied in this trial is called OM-85 (hereafter referred to as the "investigational product"). OM-85 is a medication that enhances the body's immune defense. This study aims to investigate whether the investigational product is safe and effective in preventing respiratory infections (nose, throat, and lung). The efficacy of the investigational product in recurrent respiratory infections has already been demonstrated, but the efficacy of short-term treatment needs to be confirmed and the effects of long-term treatment evaluated, in children aged between 6 months and 5 years with wheezing lower respiratory tract diseases. In order to assess efficacy, the investigational product must be compared with a placebo. This is a capsule that looks like the investigational product but contains no active ingredient. Neither the parents nor the children nor the investigator/sponsor will know which study medication (either the investigational product or the placebo) the children are taking. The children will be randomly assigned (like drawing lots) to 1 of 3 treatment groups. These treatment groups are referred to as the BV-12 arm, BV-3 arm, and placebo arm: • BV-12 arm: Children in this treatment group receive the investigational product for 10 consecutive days per month for 12 consecutive months. • BV-3 arm: Children in this treatment group receive the investigational product for 10 consecutive days per month for 3 consecutive months. They then receive the corresponding placebo for 10 consecutive days per month for 9 consecutive months. • Placebo arm: Children in this treatment group receive the placebo for 10 consecutive days per month for 12 consecutive months.
(BASEC)
Intervento studiato
During the screening visit, it will be determined whether the children are eligible to participate in the study before treatment with the study medication begins. This screening visit will take place at the trial center during the first visit (Visit 1), within 20 days prior to or on the same day as the collection of baseline values/random assignment to the treatment group, which occurs at Visit 2. The treatment phase (months 1 to 12) includes the following visits: o The visit for the collection of baseline values/assignment to the treatment group (Day 1/Visit 2) takes place at the trial center. It may coincide with the screening visit but may also take place on another day. o Three visits at the trial center (months 3, 6, and 12/Visits 3, 4, and 5) o Monthly virtual visits in the form of phone calls (months 1, 2, 4, 5, 7, 8, 9, 10, and 11) The observation phase (months 12 to 18; the first day of the observation phase begins after Visit 5 is completed) includes the following visits: o Two virtual visits in the form of phone calls (months 14 and 16) o End-of-study visit at the trial center (month 18/Visit 6) During this study, the following examinations and measures will be performed: • Collection of the children's medical history and demographic data, as well as a questionnaire on previous medications prior to entry into the study • Monitoring of the children's vital signs (including blood pressure, heart rate, and body temperature [measured in the ear]), measuring the height and weight of the children, and performing a complete physical examination • Assessment of all adverse effects of the study medication during the study • Completion of a diary including questionnaires, either in paper form or as an electronic diary • At Visits 2, 5, and 6, nasal swabs (nasal secretions) will be taken from the children to establish baseline values (the initial amount before the study medication begins) of biomarkers (a test that provides information on how cells behave). • At Visit 2, mandatory blood samples will be taken from a vein in the children's arms; at Visits 5 and 6, blood samples may be taken (voluntarily/optionally). The following blood tests will be performed on the blood samples: o Genomics (a form of genetic testing of DNA). This is a voluntary measure that is only performed at Visit 2. o Determination of the number of certain blood cells, particularly the eosinophil count in the blood. Eosinophils are immune cells involved in the development of allergies and asthma. o Immunoglobulin E (IgE). IgE is a specific type of antibody that is produced in larger amounts by the immune system in allergic patients and can specifically recognize allergens (substances that trigger allergies). o Transcriptomics (study of RNA molecules in a cell), which allows for the recognition of the overall response of the body to the study medication and the identification of biomarkers of the response to the study medication. The total amount of blood taken at each of the above-mentioned visits is approximately 4.5 ml. The maximum amount of blood taken for the purposes of the study is approximately 13.5 ml.
(BASEC)
Malattie studiate
Recurrent respiratory infection with wheezing lower respiratory tract diseases
(BASEC)
Children of both sexes aged 6 months to 5 years inclusive. For children aged ≥ 1 year: ≥ 4 respiratory infections (according to the report of the parents or the legal representative of the participant [i.e., the guardian]), including ≥ 2 lower respiratory tract diseases with wheezing episodes (of which ≥ 1 episode required hospitalization or medical consultation) within 12 months prior to enrollment in the study. OR For children aged < 1 year: ≥ 2 respiratory infections (according to the report of the parents or the legal representative of the participant), including ≥ 1 lower respiratory tract disease with wheezing episode (of which ≥ 1 episode required hospitalization or medical consultation) within 6 months prior to enrollment in the study. The parents or legal representative of the study participant have given the required written consent after being informed. The written consent must have been obtained before study-related procedures, including preliminary measures, can be performed. (BASEC)
Criteri di esclusione
Anatomical abnormalities of the respiratory tract. Other chronic respiratory diseases (e.g., tuberculosis, cystic fibrosis). Any autoimmune disease. (BASEC)
Luogo dello studio
Berna, Ginevra, Losanna, Zurigo
(BASEC)
Sponsor
OM Pharma SA
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Philipp Latzin
+41 (0)31 632 93 53
philipp.latzin@clutterinsel.chInselspital, Universitätsspital Bern Kinderklinik Freiburgstrasse 15 3010 Bern
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Berna
(BASEC)
Data di approvazione del comitato etico
31.01.2023
(BASEC)
ID di studio ICTRP
NCT05677763 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
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 (BASEC)
Titolo accademico
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 (ICTRP)
Titolo pubblico
OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness (ICTRP)
Malattie studiate
Respiratory Tract InfectionsWheezing Lower Respiratory Illness (ICTRP)
Intervento studiato
Drug: OM-85Drug: Placebo (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). (ICTRP)
Criteri di inclusione/esclusione
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. (ICTRP)
non disponibile
Endpoint primari e secondari
Rate of respiratory tract infections (RTIs) (ICTRP)
Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject;Rate of wLRIs;Rate of respiratory tract infections (RTIs);Proportion of subjects with recurrent RTIs;Proportion of subjects with wLRIs;Rate of severe wheezing lower respiratory illness (SwLRIs);Proportion of subjects with SwLRIs;Time to first, second and third RTI and wLRI;Mean duration in days per RTI;Mean duration in days per wLRI;Number of outpatient medical visits;Number of absent days from day-care;Number of antibiotic treatments for a respiratory event;Duration of antibiotic treatments for a respiratory event;Number of systemic corticosteroids, inhaled corticosteroids (ICS) and �2-agonist treatments for a wLRI;Duration of systemic corticosteroids, ICS and �2-agonist treatments for a wLRI;Symptom duration as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire;Symptom types as per the adapted WURSS-K questionnaire;Symptom severity as per the adapted WURSS-K questionnaire (ICTRP)
Data di registrazione
14.12.2022 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Lorenz Lehr, lorenz.lehr@ompharma.com, +41 22 783 14 59 (ICTRP)
ID secondari
2022-000886-42, BV-2020/08 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT05677763 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile