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

• Conditions: Grass pollen allergic rhinitis

• Registration Number: EUCTR2009-018112-26-NL
• Lead Sponsor: Weleda AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Patients:
•Written informed consent
•Age = 18 and < 60 years.
•Seasonal allergic rhinitis:
-Duration of respective complaints at least 2 years
-RAST for grass pollen: = 2
-Positive skin prick test on grass pollen
-Suffering from the following symptoms:
sneezing, itching nose, nasal obstruction and watery nasal discharge
-Severity score of at least two of the four 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

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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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
•Other allergies (no seasonal AR)

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified