NCT05677763进行中（未招募）4 期
A Randomised, Placebo-Controlled, 3-Arm, Double-Blind, Multicentre, Phase 4 Study to Assess the Efficacy of OM-85 (Broncho-Vaxom) Short- and Long-Term Treatment vs. Placebo in the Prevention of Respiratory Tract Infections in Children Aged Between 6 Months and 5 Years With Wheezing Lower Respiratory Illness
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- OM Pharma SA
- 入组人数
- 525
- 试验地点
- 82
- 主要终点
- Rate of respiratory tract infections (RTIs)
研究概览
简要总结
This study will assess the efficacy and safety of OM-85 compared to placebo in reducing the number of respiratory tract infections (RTIs) in children aged between 6 months and 5 years.
详细描述
This is a Phase 4, randomised, double-blind, placebo-controlled study to assess the efficacy and safety of short- and long-term treatment with OM-85.
The study will consist of screening (up to 20 days before randomisation), Treatment period of 12 months, and an Observational period of 6 months.
The subjects will be randomised in a ratio of 1:1:1 ratio to receive either OM-85 for 12 consecutive months (BV-12 arm), or OM-85 for 3 consecutive months followed by matching placebo for 9 consecutive months (BV-3 arm), or placebo for 12 consecutive months (Placebo arm).
The expected duration of subject participation is 18 months (+20 days).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children of either gender aged between 6 months and 5 years, at Baseline/Randomisation (Visit 2) inclusive.
- •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.
- •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.
- •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.
排除标准
- •Anatomic alterations of the respiratory tract.
- •Other chronic respiratory diseases (e.g., tuberculosis, cystic fibrosis).
- •Any autoimmune disease.
- •HIV infection or any type of congenital or iatrogenic immune deficiency (including IgA deficiency).
- •Known severe congenital heart disease.
- •Haematologic diseases.
- •Liver or kidney failure.
- •New-borns before 34 weeks of gestational age.
- •Malnutrition as per World Health Organization (WHO) definition.
- •Any known neoplasia or malignancy.
- •Treatment with the following medications:
- •Injection or oral administration of steroids within 4 weeks prior to study enrolment.
- •Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months prior to study enrolment.
- •Previous use within last 6 months of enrolment or ongoing use of bacterial lysates.
- •Any major surgery within the last 3 months prior to study enrolment.
- •Known allergy or previous intolerance to investigational medicinal products (IMP).
- •Any other clinical conditions, that in the opinion of the Investigator, would not allow safe completion of the clinical study.
- •Other household members have previously been randomised in this clinical study.
- •Subjects' families expected to relocate out of study area within 24 months of the initiation of the study.
- •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.
- •Parents or legally acceptable representative (LAR) who do not have access to internet connection.
- •Wheezing documented to be caused by gastroesophageal reflux.
研究组 & 干预措施
BV-12
Experimental
Subjects will receive OM-85 treatment for 12 consecutive months. (10 days per month)
干预措施: OM-85 (Drug)
Placebo
Placebo Comparator
Subjects will receive matching placebo for 12 consecutive months. (10 days per month)
干预措施: Placebo (Drug)
BV-3
Experimental
Subjects will receive OM-85 treatment for 3 consecutive months, followed by matching placebo for 9 consecutive months. (10 days per month)
干预措施: OM-85 (Drug)
结局指标
主要结局
Rate of respiratory tract infections (RTIs)
时间窗: 12 Months
The number of RTIs experienced by a subject during the Treatment period will be assessed.
次要结局
- Rate of severe wheezing lower respiratory illness (SwLRIs)(18 Months)
- Proportion of subjects with SwLRIs(18 Months)
- Time to first, second and third RTI and wLRI(18 Months)
- Mean duration in days per wLRI(18 Months)
- Number of antibiotic treatments for a respiratory event(18 Months)
- Duration of antibiotic treatments for a respiratory event(18 Months)
- Number of systemic corticosteroids, inhaled corticosteroids (ICS) and β2-agonist treatments for a wLRI(18 Months)
- Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI(18 Months)
- Rate of respiratory tract infections (RTIs)(18 Months)
- Proportion of subjects with wLRIs(18 Months)
- Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject(12 Months)
- Rate of wLRIs(18 Months)
- Symptom duration as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire(18 Months)
- Symptom types as per the adapted WURSS-K questionnaire(18 Months)
- Symptom severity as per the adapted WURSS-K questionnaire(18 Months)
- Proportion of subjects with recurrent RTIs(18 Months)
- Mean duration in days per RTI and acute RTI(18 Months)
- Mean duration in days per SwLRI(18 months)
- Number of healthcare resource utilisations(18 Months)
- Number of absent days from daycare(18 Months)
- Rate of wheezing lower respiratory infections (wLRIs) experienced by a subject(12 Months)
- Rate of wLRIs(18 Months)
- Rate of respiratory tract infections (RTIs)(18 Months)
- Proportion of subjects with recurrent RTIs(12 Months)
- Proportion of subjects with wLRIs(18 Months)
- Rate of severe wheezing lower respiratory illness (SwLRIs)(18 Months)
- Proportion of subjects with SwLRIs(18 Months)
- Time to first, second and third RTI and wLRI(18 Months)
- Mean duration in days per RTI(18 Months)
- Mean duration in days per wLRI(18 Months)
- Number of outpatient medical visits(18 Months)
- Number of absent days from day-care(18 Months)
- Number of antibiotic treatments for a respiratory event(18 Months)
- Duration of antibiotic treatments for a respiratory event(18 Months)
- Number of systemic corticosteroids, inhaled corticosteroids (ICS) and β2-agonist treatments for a wLRI(18 Months)
- Duration of systemic corticosteroids, ICS and β2-agonist treatments for a wLRI(18 Months)
- Symptom duration as per the adapted Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) questionnaire(18 Months)
- Symptom types as per the adapted WURSS-K questionnaire(18 Months)
- Symptom severity as per the adapted WURSS-K questionnaire(18 Months)
- Proportion of subjects who have not used antibiotics as rescue medication for RTI(18 Months)
- Proportion of subjects who have not been hospitalised for an RTI(18 Months)
- Proportion of subjects who have not been administered a systemic corticosteroid for wLRI(18 Months)
- Proportion of subjects who have not been hospitalised for more than 1 day for wLRI(18 Months)
研究者
研究点 (82)
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