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

Phase 3

Conditions: aandoeningen op keel, neus en oor gebied
grass pollen allergy
hay fever
10001708

Registration Number: NL-OMON34862

Lead Sponsor: Weleda AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

Patients:
•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

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 (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)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Days with symptom control defined by:<br /><br>a)A Total Symptom Score of <= 8 (while exposed to a mean pollen count of 20-50)<br /><br>or <= 12 (while exposed to a mean pollen count of > 50)<br /><br>and<br /><br>b)No use of rescue medication<br /><br>in the verum group compared to the placebo group in the last two weeks of<br /><br>treatment</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1.Total use of rescue medication throughout the whole treatment period.<br /><br><br /><br>2.Relevant changes in the following seasonal AR-related immunological<br /><br>parameters: IL-10, IL-12, IL-1ß, TNFa, IFN-γ, IL-5, IL-13 and IL17A.<br /><br><br /><br>3.Number of drop outs between verum and placebo group.<br /><br><br /><br>4.Safety: Adverse events and laboratory findings.<br /><br><br /><br>5.Development of the immune regulation model that is able to distinguish<br /><br>optimally between (severity of) SAR and non-SAR and predict immunological and<br /><br>clinical outcomes. </p><br>

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