E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Respiratory Tract Infections with Wheezing Lower Respiratory Illness |
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E.1.1.1 | Medical condition in easily understood language |
Respiratory Tract Infections with Wheezing Lower Respiratory Illness |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10024970 |
E.1.2 | Term | Respiratory tract infections |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary efficacy objective is to assess the efficacy of short- and long-term treatment with OM 85 vs. placebo in reducing the number of RTIs in children aged between 6 months and 5 years with recurrent RTIs associated with wLRI during the 12-month Treatment period. |
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E.2.2 | Secondary objectives of the trial |
Key secondary efficacy objective is to assess the efficacy of short- and long-term treatment with OM 85 vs. placebo in reducing the number of wLRIs during the 12-month Treatment period. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Children of either gender aged between 6 months and 5 years at Baseline/Randomisation (Visit 2), inclusive. As requested by the Central Ethics Committee, in Italy children can be enrolled if they are between 1 year and 5 years of age at baseline/Randomisation (Visit 2). 2. 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. 3. 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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E.4 | Principal exclusion criteria |
1. Anatomic alterations of the respiratory tract. 2. Other chronic respiratory diseases (e.g., tuberculosis, cystic fibrosis). 3. Any autoimmune disease. 4. HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency). 5. Known severe congenital heart disease. 6. Haematologic diseases. 7. Liver or kidney failure. 8. New-borns before 34 weeks of gestational age. 9. Malnutrition as per World Health Organization (WHO) definition, meaning children having a weight lower than the 5th percentile and higher than the 85th percentile for their age range according to WHO weight for age charts from birth to 5 years. Children of 6 months of age at enrolment will be excluded from the study if they have a weight lower than 6 kg and 6.6 kg, for girls and boys respectively. 10. Any known neoplasia or malignancy. 11. Treatment with the following medications: a. Injection or oral steroids administration within 4 weeks prior to study enrolment. b. Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to study enrolment. 12. Previous use within last 6 months of enrolment or ongoing use of bacterial lysates. 13. Any major surgery within the last 3 months prior to study enrolment. 14. Known allergy or previous intolerance to investigational medicinal products (IMP). 15. Any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study. 16. No other household members have previously been randomised in this clinical study. 17. Subjects’ families expected to relocate out of study area within 24 months of the initiation of the study. 18. 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. 19. Parents or LAR who do not have access to internet connection. 20. Wheezing documented to be caused by gastroesophageal reflux. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary efficacy endpoint is the rate of RTIs during the 12-month Treatment period, defined as the number of RTIs experienced by a subject during the Treatment period. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Rate of wLRIs during the 12-month Treatment period, defined as number of wLRIs experienced by a subject during the Treatment period.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 29 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Switzerland |
United Kingdom |
Germany |
Hungary |
Italy |
Poland |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of study is defined as the date of the last visit or last follow-up of the last subject in the study, or the date of the last contact attempt if the last subject is declared lost to follow-up. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 10 |