Randomised, double-blind and prospective clinical study to examine the mechanism of action of the Petasites hybridus leaf extract IG-RD-001 (Ze-339, petasol butenoate complex) compared to desloratadine and placebo in patients with seasonal allergic rhinitis of all degrees of severity (provoked by grasses). The treatment arm with desloratadine is an established standard treatment and is intended to ensure the comparative methodology of the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
Following a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants. The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
Following a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants. The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
Dept. of Otorhinolaryngology and Head and Neck Surgery
Düsseldorf, Germany
The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.
Time frame: 0-24 hours post nasal provocation test
Clinical symptom score (rhinorrhoea, nasal congestion, nasal itching and sneezing), assessment by the investigator (nasal secretion, irritation, occurrence of systemic symptoms), mediators in the serum, nasal secretion, nasal curettage and biopsy
Time frame: 0-24h post nasal provocation test
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Following a 3-way crossover treatment design (IG-RD-001 (Ze 339), desloratadine, placebo), a controlled, unilateral, nasal allergen provocation (grasses) will be carried out on 18 study participants. The time-dependent development of the nasal obstruction, measured via rhinomanometry before and after the allergen provocation, will be the effect parameter.