Clinical and immune modifying capacity of Broncho-Vaxom® tested by LPS challenge in healthy volunteersA randomized double-blind placebo-controlled trial - Broncho-Vaxom® immune-modifying capacity

OM Pharma SA0 个研究点开始时间: 2012年6月11日最近更新: 2013年3月4日

试验速览

暂无简介。

•Volunteers to be included in this study are those :
•- who have been informed of the study procedures and have given their written informed consent.
•- Healthy male and female of any race
•- aged 18 to 45 years
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Volunteers to be excluded from this study are those :
•- who have received systemic or inhaled corticosteroids within 4 weeks of Visit 1
•- who have smoked on a regular basis within 2 years of Visit 1 or who have a smoking history > 10 pack years
•- with an active lung disease (e.g. asthma, chronic bronchitis, COPD)
•- who have suffered from a respiratory tract infection within the 4 weeks preceding the study period
•- with predicted FEV1 below 80% at visit 1
•- with 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
•- with clinically significant laboratory abnormalities at Visit 1
•- with a platelet count = 130 x 109/L at visit 1
•- with Methacholine-test below 0.1mg at V1
•- with a clinically significant abnormal finding detected on ECG
•- with a skin prick test result >5mm and a corresponding history of allergic asthma
•- with a history of food or drug related severe anaphylactoid or anaphylactic reaction(s).

发起方