Respiratory Tract Infections with Wheezing Lower Respiratory Illness MedDRA version: 20.0 Level: HLGT Classification code 10024970 Term: Respiratory tract infections System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Broncho Vaxom®
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: OM-85
Current Sponsor code: OM-85
Other descriptive name: LYOPHILIZED BACTERIAL LYSATES OF: HAEMOPHILUS INFLUENZAE ST
Sponsors
OM Pharma SA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children of either gender aged between 6 months and 5 years, inclusive. 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Anatomic alterations of the respiratory tract. 2. Other respiratory chronic 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. 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. 10. Any known neoplasia or malignancy. 11. Treatment with the following medications: a. Systemic or oral steroids (e.g., oral prednisolone) 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;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 relative to their time at risk during the Treatment period (Visit 2 to Visit 5).;Timepoint(s) of evaluation of this end point: after 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Rate of wLRIs during the 12-month Treatment period, defined as number of wLRIs experienced by a subject relative to their time at risk during the Treatment period (Visit 2 to Visit 5).;Timepoint(s) of evaluation of this end point: after 3, 6, 9, 12 months | — |
Countries
Germany, Hungary, Italy, Poland, Switzerland, United Kingdom
Contacts
Public ContactHead of Clinical Development
OM Pharma SA
Outcome results
None listed