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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40456

Enrollment

126

Registered

2014-01-27

Start date

2014-02-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

grass pollen allergy hay fever

Interventions

Due to weather conditions the pollen level can be (too) low. In order to get the optimal conditions for the study the period of the total time for wash out and/or treatment will be extended for all

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: *Written informed consent *Age * 18 and 20 or use of rescue medication on days with a pollen count > 20

Exclusion criteria

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
1.Total use of rescue medication throughout the whole treatment period. 2.Number of drop outs between verum and placebo group. 4.Safety: Adverse events	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)