Phase II-III study to assess efficacy and safety of sublingual immunotherapy in patients suffering from grass pollen allergy

Moderate-to-severe allergic rhinitis / rhinoconjunctivitis due to grass pollen for at least two years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guideline

The primary (efficacy) endpoint is defined as the absolute differences in mean CSMS (Combined Symptom and Medication Score) during Peak Grass Pollen Period (PGPP) of each active treatment group compared to placebo treatment group.

Absolute and relative differences in mean CSMS during Grass Pollen Season (GPS) between active and placebo treatment groups., Absolute and relative differences in mean dSS during PGPP and GPS, Absolute and relative differences in mean dMS during PGPP and GPS, Global Rhinoconjunctivitis Discomfort with a Visual Analogue Scale (VAS), Change in Rhinoconjunctivitis quality of life questionnaire (RQLQ) between active and placebo treatment groups comparing basal and post-treatment scoring, Well and severe days: A well day is defined as a day without administration of any rescue medication (dMS = 0) and with dSS < 0.34 (range 0-3). A severe day is defined (acc. to Pfaar et al. 2014a) as a day with a single score = 3 in any of the six symptoms. Percentages of well and severe days will be calculated for each subject as the number of well or severe days in the PGPP and GPS in relation to the number of days comprising both periods, Symptom-free days are defined as the days with absence of symptoms (dSS = 0) and without administration of any rescue medication (dMS = 0), expressed as percentage of days during the PGPP and GPS, tNPT titrated Nasal Provocation Test: To assess the efficacy of each dose of SULGEN® Spray Phleum pratense compared to placebo. Defined as percentage of patients with an increased dosing step and the change in number of dosing steps needed to provoke a positive response in the titrated nasal provocation test (tNPT) post-treatment compared with pre-treatment (i. e. any improvement) in each of the four treatment groups. This is based on the change of the response to nasal provocation (tNPT) with

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