ISRCTN25212012已完成不适用
Clinical and immune modifying capacity of Broncho-Vaxom tested by LPS challenge in healthy volunteers
OM Pharma [Vifor Pharma] (Switzerland)0 个研究点目标入组 60 人开始时间: 2012年10月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
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
- 性别
- All
入选标准
- •1. Patients who have been informed of the study procedures and medications and have given their written informed consent
- •2. Healthy male and female of any race
- •3. Aged 18 to 45 years
排除标准
- •1. Have received systemic or inhaled corticosteroids within 4 weeks before Visit 1
- •2. Have smoked on a regular basis within 2 years before Visit 1 or who have a smoking history > 10 pack years
- •3. An active lung disease (e.g. asthma, chronic bronchitis, COPD)
- •4. Have suffered from a respiratory tract infection within 4 weeks preceding the study period.
- •5. Predicted FEV1 below 80% at visit 1
- •6. Clinically significant uncontrolled systemic disease or a history of such disease (e.g. cancer, infection, hematological disease, renal, hepatic, coronary heart disease or other cardiovascular disease, endocrinology or gastrointestinal disease) within the previous 3 months
- •7. Clinically significant laboratory abnormalities at Visit 1
- •8. A platelet count less or equal to 130 x 10@9/L at Visit 1
- •9. A result for Methacholine-test below 0.1 mg at Visit 1
- •10. Skin prick test result >5mm and a corresponding history of allergic asthma
- •11. With a clinically significant abnormal finding detected on Electrocardiogram at visit 1
- •12. A history of food or drug related severe anaphylactoid or anaphylactic reaction(s)
- •13. Are pregnant or nursing mothers
- •14. Who are of child bearing potential and who are not protected by a reliable contraceptive method (oral, subcutaneous, mechanical, or surgical contraception). Any woman who becomes pregnant during the course of the study must be discontinued, any female who starts her menarche during the trial and is not, for whatever reason, protected by a medically
- •approved contraception must be withdrawn from the trial
- •15. Known hypersensitivity to any ingredients of BV
- •16. Volunteers who are considered potentially unreliable and volunteers who may not reliably attend study drug visits
- •17. A history of drug or alcohol abuse
- •18. Are unable to perform spirometry and peak flow measurements or complete the subject's diary
- •19. Have participated in another clinical study within 3 months prior to Visit 1
研究者
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