OM-85 in Paediatric Recurrent Respiratory Tract Infections With Wheezing Lower Respiratory Illness
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
A total of 426 subjects will be randomised in the study.
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: BV-12 Subjects will receive OM-85 treatment for 12 consecutive months. (10 days per month) |
Drug: OM-85
Subjects will be administered OM-85 3.5 mg capsules by mouth once daily. (10 days per month)
|
| Experimental: BV-3 Subjects will receive OM-85 treatment for 3 consecutive months, followed by matching placebo for 9 consecutive months. (10 days per month) |
Drug: OM-85
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) |
Drug: Placebo
Subjects will be administered Placebo once daily. (10 days per month)
|
Outcome Measures
Primary Outcome Measures
- Rate of respiratory tract infections (RTIs) [12 Months]
The number of RTIs experienced by a subject relative to their time at risk during the Treatment period will be assessed.
Secondary Outcome Measures
- Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject [12 Months]
The number of wLRIs experienced by a subject relative to their time at risk 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 relative to their time at risk 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 relative to their time at risk 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 12-month 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 relative to their time at risk 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 12-month 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 RTI [18 Months]
Mean duration in days per RTI during the Treatment period and during the Observational period 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.
- 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.
- 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.
- Symptom changes in terms of types as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire [18 Months]
Symptom changes in terms of types 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 changes in terms of severity as per the adapted WURSS-K questionnaire [18 Months]
Symptom changes in terms of 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.
Other Outcome Measures
- Number of subjects with adverse events and serious adverse event [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Children of either gender aged between 6 months and 5 years, 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
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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 respiratory chronic diseases (e.g., tuberculosis, cystic fibrosis).
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Any autoimmune disease.
-
HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).
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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:
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Systemic or oral steroids (e.g., oral prednisolone) within 4 weeks prior to study enrolment.
-
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).
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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.
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Osp.Pediatr.Giov.XXIII,AOUC P.Bari | Bari | Italy | 70126 | |
| 2 | ASST Papa GiovanniXXIII,Mat.Inf.Ped | Bergamo | Italy | 24127 | |
| 3 | Azienda ospedalo universitaria | Parma | Italy | 43100 | |
| 4 | Universita degli Studi di Pavia - Fondazione IRCCS Policlini | Pavia | Italy | 27100 | |
| 5 | University of Pisa | Pisa | Italy | 56126 | |
| 6 | WWCOiT im. M. Kopernika w Lodzi, Osrodek Pediatryczny im. dr J.Korczaka | Łódź | Lódzkie | Poland | 90-329 |
| 7 | ALERGO-MED Specjalistyczna Przychodnia Lekarska Spolka z o.o. | Tarnów | Malopolskie | Poland | 33-100 |
| 8 | NSZOZ Puls - Med Anna Bogusz, Agnieszka Musielak Sp.J. | Skarżysko-Kamienna | Swietokrzyskie | Poland | 26-110 |
| 9 | ETG Skierniewice | Skierniewice | Poland | 96-100 | |
| 10 | Royal Hospital for Children and Young People | Edinburgh | United Kingdom | EH9 1LF | |
| 11 | University Hospitals of Leicester NHS Trust | Leicester | United Kingdom | LE3 9QP | |
| 12 | Royal London Hospital | London | United Kingdom | E1 4NS | |
| 13 | King's College Hospital | London | United Kingdom | SE5 9RS | |
| 14 | Royal Manchester Children's Hospital - Paediatrics - Paediatrics | Manchester | United Kingdom | M13 9WL |
Sponsors and Collaborators
- OM Pharma
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BV-2020/08
- 2022-000886-42