A study to demonstrate the efficacy of PMBL (Ismigen) in the reduction of respiratory infections in children aged 3 to 12 years.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Lallemand Pharma Europe filial af Lallemand Pharma AG Schweiz

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2026-04-23

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Lallemand Pharma AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

The primary objective is to demonstrate that PMBL® sublingual tablet used according to the SmPC instructions during the fall winter period is able to reduce the incidence of respiratory tract infections in children 3 to 12 years old during the whole observation period when compared to the Placebo.

Secondary objectives 1

1. The secondary objectives are: -To demonstrate a reduction of the total duration of episodes of respiratory tract infections in the PMBL® treated group versus Placebo. -To demonstrate a reduction of antibiotics intake for respiratory tract infection treatment in the PMBL® treated group compared to the Placebo group. - To demonstrate a reduction of the medico-economic burden of respiratory tract infections in children with PMBL® sublingual tablets. -To describe the safety of PMBL® sublingual tablet.

Conditions and MedDRA coding

Respiratory Tract Infections

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Patients will be enrolled if they meet all of the following criteria: 1. Children of both genders aged from 3 to 12 years. 2. Written informed consent obtained from the parents/legaly authorized representatives 3. Written assent obtained from the subject from 7 years 4. Subject presenting with a susceptibility to respiratory tract infections according to the investigator 5. No respiratory tract infection within 15 days before the randomization visit 6. All girls of childbearing potential have a negative pregnancy urine testing at randomization visit and are informed and their parents as well of the requirement for contraception during the study. 7. A cooperative attitude and ability to correct use of PMBL® tablet.

Exclusion criteria 1

1. Patients will not be enrolled if one of the following criteria is present: 1. Subject treated with bacterial lysates within the previous 6 months prior to V1 or ongoing treatment 2. Body temperature ≥ 37.5°C at the randomization visit. 3. Pregnant/Lactating female or with sexual activity without hormonal contraception, intrauterine device or barrier methods. 4. Primary or secondary immunodeficiency, cystic fibrosis, bronchiectasis, alpha-1 antitrypsin deficiency, malignancy, endocrinological diseases or other chronic respiratory diseases, except asthma and allergic rhinitis. 5. Known sensitivity to the components of study medication. 6. Any major surgery within the last 3 months prior to study enrolment or planned to occur within the duration of study. 7. Treatment with the following medications: a. Injection or oral administration of steroids within 4 weeks prior to study enrolment. b. Previous and/or concomitant immunosuppressants, immunostimulants, allergen-immunotherapy or gamma globulins within 6 months prior to study enrolment. 8. Inability to understand or comply with study procedures or with study treatment intake. 9. Subject participating in another interventional clinical study at the time of screening visit.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Rate of Respiratory Tract Infections (RTIs): the number of RTIs experienced by a subject throughout the study (3 month-treatment period and 4 month-follow-up) will be assessed.

Secondary endpoints 1

1. - % of pts free of RTI during the overall study period - Mean duration in days per RTI during the overall study period (OST) – No. of days with RTI during the OST – No. of days of antibiotics use during the OST - Total no. of workdays lost by parents due to their child’s RTI during the OST – No. of physician consultations due to RTI or related complications – No. of antibiotic treatments (courses) for a respiratory event during the OST – No. of pts with (serious) AE and (serious) ADR

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Lallemand Pharma Europe filial af Lallemand Pharma AG Schweiz

Sponsor organisation

Lallemand Pharma Europe filial af Lallemand Pharma AG Schweiz

Address

Bredstrupvej 33

City

Grenaa

Postcode

8500

Country

Denmark

Scientific contact point

Organisation

Lallemand Pharma Europe filial af Lallemand Pharma AG Schweiz

Contact name

Dr. Frédéric Durmont

Public contact point

Organisation

Lallemand Pharma Europe filial af Lallemand Pharma AG Schweiz

Contact name

Dr. Frédéric Durmont

Third parties 1

Locations

1 EU/EEA country · 10 investigational sites

By country

Investigational sites

Results and documents

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

Documents 11 files

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

Application history

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