The trial is performed to asses efficacy and safety of a sublingual extract of a six grass pollen mixture
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
Solution for sublingual application containing allergen extracts of 6 grass pollen species (Holcus lanatus, Dactylus glomerata, Lolium perenne, Phleum pratense, Poa pratensis, Festuca pratensis) pollen allergen extract. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.
Solution for sublingual application containing Placebo. The study solution was applied sublingually, kept under the tongue for 3 minutes, and swallowed thereafter.
Allergopharma GmbH & Co. KG
Reinbek, Germany
Symptom and Medication Score (SMS)
The primary endpoint is the change of the area under the curve (AUC, derived from an analysis period of 42 days) of the daily sum of the Symptom and Medication Score (SMS) from the baseline measurement to the measurement after 1.5 years of therapy.
Time frame: 1.5 years of therapy
Visual Rating Scale
Patients' Assessment of severity of symptoms at the end of each season on a 10 points visual rating scale (VRS)
Time frame: 1.5 years
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