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A study to demonstrate the efficacy of PMBL (Ismigen) in the reduction of respiratory infections in children aged 3 to 12 years.
EU CTIS ID: 2025-524212-11-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.