OM 85 in Paediatric Recurrent Respiratory Tract Infections with Wheezing Lower Respiratory Illness

Overview

Sponsor-declared trial summary

Key facts

Sponsor

OM Pharma SA

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

25 Nov 2022 → ongoing

Decision date (initial)

2024-06-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

OM Pharma SA

External identifiers

EU CT number

2024-511581-37-00

EudraCT number

2022-000886-42

ClinicalTrials.gov

NCT05677763

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

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 objectives 1

1. 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.

Conditions and MedDRA coding

Respiratory Tract Infections with Wheezing Lower Respiratory Illness

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

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.

Exclusion criteria 20

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. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 1

1. Rate of wLRIs during the 12-month Treatment period, defined as number of wLRIs experienced by a subject during the Treatment period.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

OM Pharma SA

Sponsor organisation

OM Pharma SA

Address

Rue Du Bois-Du-Lan 22

City

Meyrin

Postcode

1217

Country

Switzerland

Scientific contact point

Organisation

OM Pharma SA

Contact name

Clinical Development Department

Public contact point

Organisation

OM Pharma SA

Contact name

Clinical Development Department

Third parties 12

Locations

4 EU/EEA countries · 27 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 57 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

12 submissions — initial application plus substantial / non-substantial modifications