Efficacy and tolerability of Citrus/Cydonia comp.® solution for injection in patients with grass pollen seasonal allergic rhinitis: Randomised, double-blind, placebo-controlled comparative clinical trial with three parallel treatment groups - The CiSAR Study

Hogeschool Leiden0 个研究点目标入组 126 人开始时间: 待定最近更新: 2024年4月29日

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•Patients: *Written informed consent *Age * 18 and < 60 years. *Seasonal AR: -Duration of respective complaints at least 2 years -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

•Patients: *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 . * Use of cromoglycates *Other allergies (non seasonal allergies)

发起方

Hogeschool Leiden