Study on the efficacy and safety of three different doses of Lais Ambrosia tablets in patients with allergic rhinoconjunctivitis to pollen of Ambrosia - Sublingual immunotherapy with Lais Ambrosia Tablets

OFARMA0 个研究点开始时间: 2012年3月2日最近更新: 2013年9月30日

适应症

试验速览

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•-Signed Informed Consent -Male or female patients aged between 18 and 75 years with a documented history of at least two years of rhinitis and / or moderate to severe allergic rhinoconjunctivitis to ragweed pollen seasonal allergic asthma with or without controlled. -clinically relevant sensitization to ragweed pollen -Positive clinical history to ragweed pollen -Availability to attend the study visits requested by the protocol during the study participation -Negative Pregnancy Urinary test (if female in fertile age) -If woman is of fertile age, she has been using a highly efficacious method of birth control for at least one month before the study enrolment and agrees to continue the use for the entire duration of the study. -Capable to fully understand the protocol and be compliant to the instructions reported in the protocol itself. -Positive response to the TPN test.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•- Concomitant participation in other interventional clinical trials - Previous immunotherapy with ragweed allergen in the last 3 years. - Ongoing immunotherapy. - clinically relevant sensitization to other stagional aereous allergens such as Cupressacee, Graminacee, Parietaria, Artemisia, Betulacee, and/or to perennial allergens like house dust mites, cats and dogs dander. - Patients being in any relationship or dependence with the sponsor and/or investigator - Other reasons contra-indicating an inclusion into the trial according to the investigator’s estimation (e.g. poor compliance, inability of the patient to understand study documents and instructions) - Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection - Predominant perennial allergic rhinitis - Partly controlled or uncontrolled asthma - Chronic asthma or emphysema, particularly with a FEV <70% of the predicted value - Galactose-intolerance or malabsorption syndrome - Active tuberculosis - Generally inflammatory as well severe acute and chronic inflammatory diseases - Irreversible secondary disorders at the target organ (e.g. emphysema, bronchoectasis) - Immune deficiency (for example induced by immunosuppressive drugs) - Physician diagnosed diseases of the liver, spleen, nervous system, thyroidal gland as well as rheumatic diseases, based on an autoimmune mechanism - Malignancy - Alcohol abuse.

发起方

OFARMA