The study is assessing efficacy and safety of three different dosage regimens of grass pollen sublingual immunotherapy in adult patients suffering from grass pollen related rhinoconjunctivitis.
Patients with seasonal grass pollen related rhinoconjunctivitis will be randomized to one of four treatment groups at 41 centres in Europe. Each treatment group will consist of approximately 150 patients and 150 patients will be randomized to a placebo group. The study will consist of a screening phase, a treatment phase and a variable maintenance period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
605
Patients will receive drops of grass pollen immunotherapy sublingually
Patients will receive matching placebo sublingually
Primary efficacy variable is based on pollen season rhinoconjunctivitis Total Symptom Score (PS.RTSS)
Time frame: One year
Diarised Period RTSS on severity of rhinoconjunctivitis scores and rescue medication usage will be calculated to assess efficacy. Safety will be assessed through AE profile, the assessment of routine safety tests.
Time frame: one year
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