CTIS2024-511083-90-00进行中（未招募）1 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 - BV-2020/09
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- OM Pharma SA
- 入组人数
- 288
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Children of either gender, aged between 6 and 72 months (5 years inclusive)., Children with recurrent wheezing: a. For ICS/LTRA naïve patients or intermittent users: =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, as reported by parents or LAR of subject, in the 12 months prior to enrollment. b. For ICS/LTRA daily users: =1 severe WE (i.e., treated with OCS or having triggered an ED visit/hospitalization) OR =2 WEs including 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. Note: While WE counted for enrollment are based on parent reporting, the PI must ensure that they fulfill the WE definition of the protocol., Up-to-date vaccination status as per applicable State Or Country Vaccination Requirements for school/daycare 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.
排除标准
- •Known anatomic alterations of the respiratory tract., Treatment with the following medications: a. Systemic (intravenous or intramuscular) or oral corticosteroids or OCS (e.g., oral prednisolone) within 4 weeks before study enrollment. b. 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., 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)., Wheezing documented to be caused by gastroesophageal reflux., Other known chronic respiratory diseases (e.g., tuberculosis or cystic fibrosis)., Any known autoimmune disease., Known HIV infection or any known type of congenital or iatrogenic immune deficiency (including IgA 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 in the opinion of the Investigator, this would not allow safe completion of the clinical study., Any known neoplasia or malignancy.
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