EUCTR2016-002705-19-IT进行中（未招募）1 期
A phase IV, randomized, controlled, double-blind study on efficacy and safety of OM-85 in children with recurrent respiratory tract infections - OMPeR
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Provision of written informed consent from parents/legal guardian prior to any study procedures
- •Preschool children of both gender, aged 1 to 6 years
- •Six or more acute respiratory tract illnesses in the previous year or 4 episodes of infectious bronchospasm (according to medical records from outpatient clinics)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Anatomic alterations of the respiratory tract
- •Other chronic respiratory diseases (i.e., persistent wheezing requiring stable therapy with inhalatory steroids, tuberculosis or cystic fibrosis)
- •Severe primary immunodeficiency or HIV infection
- •Any autoimmune disease
- •Liver or kidney failure
- •Malnutrition
- •Any known neoplasia or malignancy
- •Treatment with the following medications: Antibiotics, systemic, inhaled or oral steroids (e.g., oral prednisolone) within 4 weeks before Visit 1, oral vaccination with live vaccine within 4 weeks before Visit 1, long-term azithromycin therapy within 3 months before Visit 1, previous and/or concomitant immunosuppressants, Immunostimulants, gamma globulins, or anticonvulsive drugs therapy within 6 months before Visit 1
- •Any major surgery within the last 3 months prior to study enrolment
- •Known allergy or previous intolerance to study medication or to any components/excipients of the study medication;
- •Severe immunodeficiency.
- •Any other clinical conditions, in the opinion of the investigator, that would not allow safe completion of the clinical study
- •Parents/legal guardians not willing or unable to give written informed consent
- •Participant's families may not be expected to relocate out of study area within 1 year of the initiation of 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).
研究者
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