Grass pollen allergic rhinitis
Conditions
Interventions
Trade Name: Gencydo 1%
Product Name: Citrus/ Cydonia comp.
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 0
CAS Number: 0
Current Sponsor code: 0
Other descriptive name: Citrus Limon
Sponsors
Weleda AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients: •Written informed consent •Age = 18 and 20 or use of rescue medication on days with a pollen count > 20 Healthy volunteers: •Written informed consent •Age = 18 and =65 years) no F.1.3.1 Number of subjects for this age range
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 •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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Clinically relevant reduction of symptom severity of grass pollen rhinitis ;Secondary Objective: 2. To examine the safety of treatment 3. To examine treatment effects on immunological parameters 4. To develop and validate an immunological model ;Primary end point(s): “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 treatment group compared to the placebo group in the last two weeks of treatment The use of rescue medication has an impact on symptom severity. Therefore, the primary endpoint is a combined parameter reflecting both symptom severity and the intake of rescue medication. The “number of days with symptom control” is defined as the number of days without intake of rescue medication and a symptom score below a pre-defined and clinically justified threshold (European Medicines Agency, 2009). Definition of this threshold is related to the actual pollen count: With a pollen count > 50, a total symptom score (TSS) of = 12 without rescue medication is considered a clinically relevant reduction. With a pollen count ranging from 20 to 50, a TSS of = 8 without rescue medication is considered a clinically relevant reduction of symptoms. Superiority of treatment with Citrus/Cydonia comp. is accepted if the mean number of days with symptom control in the two treatment groups results in a difference of at least 30% in favour of Citrus/Cydonia comp in the last two weeks of treatment. Severity of symptoms for the day will be recorded every evening in an online questionnaire by the patient. This questionnaire measures the severity of nasal symptoms (nasal obstruction, itching nose, sneezing and watery nasal discharge) and non-nasal symptoms (itchy/burning eyes, watery eyes, redness of eyes and itching ears/throat). The total Nasal Score (TNS) and the total Non Nasal Score (TNNS) can vary | — |
Countries
Netherlands
Outcome results
None listed