Safety and Tolerability Study of Ragweed SLIT Tablets
الكلمات الدالة
نبذة مختصرة
تواريخ
آخر التحقق: | 09/30/2010 |
تم الإرسال لأول مرة: | 10/12/2010 |
تم إرسال التسجيل المقدر: | 10/18/2010 |
أول نشر: | 10/19/2010 |
تم إرسال آخر تحديث: | 11/04/2010 |
آخر تحديث تم نشره: | 11/06/2010 |
تاريخ بدء الدراسة الفعلي: | 12/31/2008 |
تاريخ الإنجاز الأساسي المقدر: | 03/31/2009 |
التاريخ المتوقع لانتهاء الدراسة: | 09/30/2009 |
حالة أو مرض
التدخل / العلاج
Drug: Sublingual tablet of ragweed pollen allergen extract
مرحلة
مجموعات الذراع
ذراع | التدخل / العلاج |
---|---|
Placebo Comparator: 1 | |
Experimental: 2 |
معايير الأهلية
الأعمار المؤهلة للدراسة | 18 Years إلى 18 Years |
الأجناس المؤهلة للدراسة | All |
يقبل المتطوعين الأصحاء | نعم |
المعايير | Inclusion Criteria: - written consent - male or female subjects from 18 yo 60 years old and in general good health - for women of child bearing potential: negative urine pregnancy test and use of medically effective contraceptive method - symptoms of ragweed pollen induced allergic rhinitis for at least the last 2 years - sensitization to ragweed pollen as demonstrated with positive skin prick test to ragweed pollen and specific IgE level (ragweed pollen) > 0.70 kU/l at screening - FEV1 at least of 80% of predicted value at screening Exclusion Criteria: - past or current disease which, as judged by the investigator, may affect the outcome of this study - history of life-threatening asthma - asthma requiring daily treatment (whatever the pharmaceutical class) - pregnant or lactating women - subjects who previously received desensitisation treatment to ragweed pollen and/or other Asteraceae or who plan to start desensitisation treatment during this study - symptoms during the treatment phase due to a sensitivity to a second allergen - subjects treated with ongoing immunotherapy with another allergen |
النتيجة
مقاييس النتائج الأولية
1. Safety, tolerability as indicated by adverse events and safety laboratory evaluation assessed every day over 2 weeks [2 weeks]
مقاييس النتائج الثانوية
1. Immunological markers (IgE and IgG4) [2 weeks]