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

Phase 3

Completed

• Conditions: grass pollen allergy; hay fever; 10001708

• Registration Number: NL-OMON40456
• Lead Sponsor: Hogeschool Leiden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 126

Inclusion Criteria

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

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 . * Use of cromoglycates *Other allergies (non seasonal allergies)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>1.Total use of rescue medication throughout the whole treatment period.<br /><br>2.Number of drop outs between verum and placebo group. 4.Safety: Adverse events </p><br>