Efficacy and tolerability of Citrus/Cydonia comp.® 1% solution for injection in patients with grass pollen seasonal allergic rhinitis: A randomised, double-blind, placebo-controlled clinical trial - The CiSAR Study

Weleda AG0 个研究点目标入组 120 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Written informed consent
•Age >= 18 and < 60 years.
•Seasonal AR:
•-Duration of respective complaints at least 2 years
•-RAST for grass pollen: >= 2
•-Suffering from the following nasal symptoms:
•sneezing, itching nose, nasal obstruction and watery nasal discharge
•-Severity score of at least two of the four nasal symptoms >= 2; ranging from 0 = not present to 3 = severe.
•-Suffering from the following non-nasal symptoms: itchy/burning eyes, watery eyes, redness of eyes and itching ears/throat
•-Severity score of at least two of the four non-nasal symptoms >= 2; ranging from 0 = not present to 3 = severe
•- The necessity to use antihistamines and/or corticosteroids for treatment of symptoms for at least two previous years
•- Average Total Symptom Score in the wash-out period >= 9 on days with a pollen count > 20 or use of rescue medication on days with a pollen count > 20;Healthy volunteers:
•Written informed consent
•Age >= 18 and < 60 years
•RAST for seasonal AR related grass and birch pollen = 0
•No history of seasonal AR symptoms for at least 2 years

•Chronic autoimmune disease such as Diabetes Mellitus type 1, Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis or Crohn*s disease
•Known hypersensitivity to one of the constituents of Citrus/Cydonia comp.®
•Participation in a further clinical trial at the same time or within 4 weeks prior to enrolment into this study
•Previous use of medicinal products containing Citrus and/or Cydonia
•Pregnancy or lactation
•Severe internal or systemic disease (e.g. cardiac, hepatic, renal diseases)
•A known history of drug, alcohol and/or medication dependence or addiction
•Immunotherapy in the last two years
•Other allergies (non seasonal allergies);Healthy volunteers:
•Nasal seasonal AR related symptoms during the pollen season: sneezing, itching nose, nasal obstruction and watery nasal discharge
•Chronic inflammatory autoimmune disease such as Diabetes Mellitus type 1, Rheumatoid Arthritis, Multiple Sclerosis, Psoriasis or Crohn*s disease
•Participation in a further clinical trial at the same time or within 4 weeks prior to enrolment into this study.
•Pregnancy or lactation
•Severe internal or systemic disease ( e.g. cardiac, hepatic, renal diseases)
•A known history of drug, alcohol and/or medication dependence or addiction
•Immunotherapy in the last two years
•Other allergies (no seasonal AR)

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