2025-524212-11-00招募中4 期
A randomized double-blind placebo-controlled study to demonstrate the efficacy of PMBL® sublingual tablets in reducing the incidence of respiratory tract infections in children aged 3-12 years (PIRTIK).
Lallemand Pharma Europe filial af Lallemand Pharma AG Schweiz10 个研究点 分布在 1 个国家目标入组 224 人开始时间: 2026年5月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 224
- 试验地点
- 10
- 主要终点
- 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.
研究概览
简要总结
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.
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients will be enrolled if they meet all of the following criteria:
- •Children of both genders aged from 3 to 12 years.
- •Written informed consent obtained from the parents/legaly authorized representatives
- •Written assent obtained from the subject from 7 years
- •Subject presenting with a susceptibility to respiratory tract infections according to the investigator
- •No respiratory tract infection within 15 days before the randomization visit
- •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.
- •A cooperative attitude and ability to correct use of PMBL® tablet.
排除标准
- •Patients will not be enrolled if one of the following criteria is present:
- •Subject treated with bacterial lysates within the previous 6 months prior to V1 or ongoing treatment
- •Body temperature ≥ 37.5°C at the randomization visit.
- •Pregnant/Lactating female or with sexual activity without hormonal contraception, intrauterine device or barrier methods.
- •Primary or secondary immunodeficiency, cystic fibrosis, bronchiectasis, alpha-1 antitrypsin deficiency, malignancy, endocrinological diseases or other chronic respiratory diseases, except asthma and allergic rhinitis.
- •Known sensitivity to the components of study medication.
- •Any major surgery within the last 3 months prior to study enrolment or planned to occur within the duration of study.
- •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.
- •Inability to understand or comply with study procedures or with study treatment intake.
- •Subject participating in another interventional clinical study at the time of screening visit.
研究组 & 干预措施
ISMIGEN tabletki podjezykowe
Test
干预措施: ISMIGEN tabletki podjezykowe (Drug)
PLACEBO
Placebo
干预措施: PLACEBO (Drug)
结局指标
主要结局
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.
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.
次要结局
- - % 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
研究者
Dr. Frédéric Durmont
Scientific
Lallemand Pharma Europe filial af Lallemand Pharma AG Schweiz
研究点 (10)
Loading locations...
相似试验
招募中
3 期
Multicenter clinical trial to evaluate efficacy and safety of sublingual immunotherapy in patients allergic to house mites, with rhinitis/rhinoconjunctivitis with or without mild to moderate asthma2023-505918-14-00Inmunotek S.L.147
招募中
Phase 3 4
To evaluate the safety and efficacy of orally administered supplement SJ29 Capsule in sickle cell anemia patientsCTRI/2024/07/070723Athulya Ayurvedic Medical Research Centre10
招募中
3 期
In this study participants with Progressive Pulmonary Fibrosis is evaluated for the Safety, Efficacy and Tolerability of the BMS- 986278.CTRI/2024/10/075478Bristol-Myers Squibb Company1,092
尚未招募
Phase 3 4
Evaluating the Benefits of Ayurvedic Therapies (Panchtikta Basti and Palash Arka) in Managing Diabetes (Madhumeha)CTRI/2025/07/090302PG Department of Panchkarma Post Graduate Institute of Ayurveda DSRRAU Jodhpur30
尚未招募
Phase 3 4
Evaluating The desired effect Of the drug Imeglimin In Patients With Polycystic Ovarian SyndromeCTRI/2024/06/068921Riya Sharma self100