Efficacy of PMBL Sublingual Tablet Combination Therapy in Reducing the Incidence of Respiratory Tract Infections in Children Aged 3-12 Years: A Randomized Controlled Trial
- Trial ID
- 2025-524212-11-00
- Protocol
- LPI-2501
Trial statistics
Diseases & Conditions
Objectives
The primary objective is to evaluate the efficacy of PMBL® sublingual tablets in reducing the incidence of respiratory tract infections in children aged 3 to 12 years during the fall and winter period compared to a placebo. Secondary objectives include:
- Demonstration of a reduction in the total duration of infection episodes.
- Reduction in antibiotic intake for the treatment of respiratory infections.
- Reduction of the medico-economic burden associated with these infections.
- Description of the safety profile of the sublingual administration.
Participants
The sponsor did not provide information regarding the total number of participants. The study population consists of children of both genders aged between 3 and 12 years who demonstrate a susceptibility to respiratory tract infections. Eligible subjects must not have experienced a respiratory infection within 15 days prior to randomization. Inclusion requires the ability to correctly use a sublingual tablet and a cooperative attitude. For female subjects of childbearing potential, a negative pregnancy test is required at the time of randomization.
Plans and Procedures
This post-authorization efficacy study is a randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy of sublingual tablets containing a bacterial mixture in reducing the incidence of respiratory tract infections in children aged 3 to 12 years. Participants will undergo a screening process to confirm eligibility based on age, susceptibility to infections, and the absence of recent illness. Following randomization, subjects will be assigned to receive either the active treatment or a placebo. The clinical observation includes a 3-month treatment period followed by a 4-month follow-up period. The primary endpoint is the rate of infections experienced throughout the entire study duration. Secondary endpoints include the percentage of subjects remaining infection-free, the mean duration of infections, and the frequency of antibiotic use. The overall period of participant involvement encompasses the treatment and follow-up phases to assess the cumulative impact on respiratory health.
Treatment
The experimental treatment consists of ISMIGEN, an oral immunotherapy administered as a sublingual tablet. Each dose contains 50 mg of a mixture of bacterial antigens, including Haemophilus influenzae, Klebsiella ozaenae, Klebsiella pneumoniae, Neisseria catarrhalis, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, and Streptococcus viridans. The administration is via the sublingual route.
The control group receives a placebo, which is administered through sublingual use with a dose of 0 mg.
Efficacy
The primary efficacy endpoint is the rate of respiratory tract infections, defined as the total number of respiratory tract infections experienced by a subject throughout the 3-month treatment period and the subsequent 4-month follow-up period.
Secondary efficacy parameters include:
- The percentage of patients free of respiratory tract infections during the overall study period.
- The mean duration in days per infection during the overall study period.
- The total number of days with infection during the overall study period.
- The number of days of antibiotic use during the overall study period.
- The total number of workdays lost by parents due to the child's infection during the overall study period.
- The number of physician consultations due to infection or related complications.
- The total number of antibiotic treatments for a respiratory event during the overall study period.
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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
- 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.
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 Poland | Recruiting | 15 May 2026 | 224 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
PLACEBO | Placebo | — | SUBLINGUAL USE | 0 | 3 | SUB21402 |
ISMIGEN tabletki podjezykowe | Test | TABLETKI PODJEZYKOWE | SUBLINGUAL USE | 50 | 3 | PRD746485 |