NCT05857930进行中（未招募）2 期
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Phase 2 Study to Assess the Efficacy and Safety of Daily OM-85 Treatment vs. Placebo Given in Children Aged 6 Months to 5 Years With Recurrent Wheezing
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- OM Pharma SA
- 入组人数
- 296
- 试验地点
- 69
- 主要终点
- Rate of Wheezing/Asthma like episodes (WEs)
研究概览
简要总结
This study will assess the efficacy and safety of daily OM-85 treatment compared to placebo in children aged 6 months to 5 years with recurrent wheezing
详细描述
This study is a 12-months phase 2, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of daily treatment with OM-85 compared to placebo, when given on top of standard of care treatment, in reducing wheezing/asthma like episodes (WEs) during the 6-month treatment period in children aged 6 months to 5 years with previous recurrent WEs.
Patients will be randomized in a 1:1 ratio to OM-85 or placebo. The study consists of screening period (Day -20 to Day -1), a treatment period of 6 months, and an observational period of 6 months without treatment. Thus, the total duration of the study for each patient will be 12 months (±10 days) + up to 20 days for screening.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who meet all the following criteria will be included in the study:
- •Children of either gender, aged between 6 and 72 months (5 years inclusive).
- •Children with recurrent wheezing:
- •For ICS/LTRA naïve patients or intermittent users (patients using ICS treatment only during an upper RTI to prevent WE): ≥2 WEs including at least 1 severe episode (i.e., treated with OCS OR having triggered an ED visit/hospitalization), OR ≥3 WEs including one that triggered an unscheduled physician visit, in the 12 months prior to enrollment.
- •For ICS/LTRA daily users: ≥1 severe WE (i.e., treated with OCS OR having triggered an ED visit/hospitalization) OR ≥2 WEs including at least one that triggered an unscheduled physician visit, as reported by parents or LAR of subject (i.e., guardians), in the 12 months prior to enrollment, while being on their daily controller therapy (at current dose or higher).
- •Up-to-date vaccination status as per applicable State or country Vaccination Requirements for school/day-care entry.
- •Parents or LAR have provided the appropriate written informed consent. Written informed consent must be provided before any study-specific procedures are performed including screening procedures.
- •Note: If a subject is experiencing respiratory symptoms at time of screening, he/she could only be randomized once symptoms have resolved for at least one week.
排除标准
- •Known anatomic alterations of the respiratory tract.
- •Wheezing documented to be caused by gastroesophageal reflux.
- •Other known chronic respiratory diseases (e.g., tuberculosis or cystic fibrosis).
- •Any known autoimmune disease.
- •Known human immunodeficiency virus (HIV) infection or any known type of congenital or iatrogenic immune deficiency (including immunoglobulin (Ig) A deficiency).
- •Known acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal function abnormalities.
- •Children born prematurely i.e., before 34 weeks of gestational age.
- •Children with an abnormally low or high weight for their age and height, if this would not allow safe completion of the clinical study in the opinion of the investigator.
- •Any known neoplasia or malignancy.
- •Treatment with the following medications:
- •Systemic corticosteroids within 4 weeks before study enrollment.
- •Previous and/or concomitant immunosuppressants, immunostimulants, or gamma globulins within 6 months before study enrollment.
- •Any major surgery within the last 3 months prior to study enrollment or planned during the study duration.
- •Known allergy or previous intolerance to investigational drug.
- •Any other clinical conditions, which in the opinion of the Investigator, would not allow safe completion of the clinical study.
- •Other household members have previously been randomized in this clinical study and have not completed their 6-month treatment period.
- •Inability to comply with the study requested visit schedule (e.g., expected relocation within 12 months of the screening for the study).
- •Currently enrolled in or has completed any other investigational device or drug study <30 days prior to screening or receiving other investigational agent(s).
- •Note: Subjects with past, present, or at risk of COVID-19 should not be excluded from the study.
研究组 & 干预措施
Placebo
Placebo Comparator
Patients will receive placebo capsules as a treatment for 6 months and will be under observation for 6 months.
干预措施: Placebo (Drug)
OM-85
Experimental
Patients will receive OM-85 capsules as a treatment for 6 months and will be under observation for 6 months.
干预措施: OM-85 (Drug)
结局指标
主要结局
Rate of Wheezing/Asthma like episodes (WEs)
时间窗: 6 Months
To assess the efficacy of OM-85 in reducing the rate of WEs compared to placebo during the 6-month Treatment period in children aged 6 months to 5 years with previous recurrent WEs.
次要结局
- Rate of WEs and severe WEs(From Month 6 up to Month 12)
- Number of WE requiring OCS treatments during 6-month observational period(From Month 6 up to Month 12)
- Number of medical visits(12 Months)
- Number of days absent from daycare/school(12 Months)
- Rate of severe WEs(6 Months)
- Number of WE requiring oral corticosteroid (OCS) treatment during 6-month treatment period(6 Months)
- Level of severity of RTI symptoms (Absent/Mild/Moderate/Severe)(12 Months)
- Number of days with WEs(6 Months)
- Time to first, second and third WE(12 Months)
- Number of antibiotic cycles(12 Months)
- Number of routine asthma treatment(12 Months)
- Duration of routine asthma treatment(12 Months)
- Number of work days when parents/LAR had to miss work or had their productivity(12 Months)
- Duration in days of WEs and severe WEs(12 Months)
- Time to treatment failure(12 Months)
- Number of days with respiratory tract infection (RTIs) symptoms(12 Months)
- Percentage of patients with recurrent wheezing(12 Months)
- Number of patients with adverse events (AEs)(12 Months)
- Rate of WE requiring oral corticosteroid (OCS) treatment during 6 month treatment period(6 Months)
- Rate of WE requiring OCS treatments during 6-month observational period(From Month 6 up to Month 12)
研究者
研究点 (69)
Loading locations...
相似试验
终止
3 期
Study of Rapastinel as Monotherapy in Patients With Major Depressive Disorder (MDD)Depressive Disorder, MajorNCT03675776Naurex, Inc, an affiliate of Allergan plc50
已完成
1 期
Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)OsteoporosisNCT01011725Merck Sharp & Dohme LLC67
终止
3 期
Study of Rapastinel as Monotherapy in Patients With MDDDepressive Disorder, MajorNCT03560518Naurex, Inc, an affiliate of Allergan plc439
终止
3 期
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD)Still's Disease, Adult-OnsetStill's Disease, Juvenile-OnsetNCT03265132Swedish Orphan Biovitrum13
已完成
2 期
Study to Assess Safety and Efficacy of Ifetroban for Treatment of Portal Hypertension in Cirrhotic PatientsPortal HypertensionLiver CirrhosisNCT02802228Cumberland Pharmaceuticals30