Investigation of a preseasonal rush treatment scheme with Depigoid® Grass Mix as an add-on therapy in patients with allergic rhinitis and/or rhinoconjunctivitis sensitized to grass pollen

INTERVENTION: Product Name: Depigoid Gräser‐Mix Pharmaceutical Form: Solution for injection INN or Proposed INN: NA CAS Number: NA Current Sponsor code: Freeze‐dried depigmented and glutaraldehyde‐polymerised allergen extract of the pollen of Phleum pra Other descriptive name: NA Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 0.5‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Intermittent rhinitis and/or rhinoconjunctivitis with or without asthma bronchial caused by clinical relevant sensitisation against grass pollen. ; MedDRA version: 8.1 Level: LLT Classification code 10039083 Term: Rhinitis PRIMARY OUTCOME: Main Objective: The objective of the study is the investigation of the efficacy and safety of a preseasonal rush treatment scheme with Depigoid® Grass Mix as an add‐on therapy in patients with intermittent allergic rhinitis and/or rhinoconjunctivitis sensitized to grass pollen.; ; Primary criterion; ; Symptom load for rhinitis and/or rhinoconjunctivitis (combined symptom and medication scores in the second season); Primary end point(s): The objective of the study is the investigation of the efficacy and safety of a preseasonal rush treatment scheme with Depigoid® Grass Mix as an add‐on therapy in patients with intermittent allergic rhinitis and/or rhinoconjunctivitis sensitized against grass pollen.; ; Primary criterion; ; Symptom load for rhinitis and/or rhinoconjunctivitis (combined symptom and medication scores in the second season); Secondary Objective: Secondary criteria; ·Symptom load for rhinitis and/or rhinoconjunctivitis (combined symptom and medication scores in the first season); ·Symptom load for asthma (combined symptom and medication scores) in both seasons; ·Titrated specific nasal challenge test at selected centers; ·Titrated skin prick test; ·Symptom scores (rhinitis and/or rhinocojunctivitis and asthma sepa‐rately) on a scale from 0‐3 (none – severe) in both seasons; ·Rhinitis/Rhinoconjunctivitis; ·Obstruction; ·Sneezing; ·Rhinorrhea; ·Nasal itching; ·Ocular itching; ·Asthma; ·Chest tightness; .Shortness of breath; ·Cough; ·Wheezing ; ·Percentage of symptom improvement according to symptom score; ·Medication scores in both seasons; ·Rhinitis and/or rhinoconjunctivitis; ·H1‐blocking agent (Xusal®): 1 point per tablet; ·Nasal steroid (Nasonex®): 2 points per daily dose *; ·Oral Steroids (Decortin® 50 mg): 3 points per tablet **; ·Asthma; [...] for more please refer to protocol; INCLUSION CRITERIA: 1.Prior to study specific examinations the patient has to give his/her written informed consent 2.Patients (= 12 years old) with a history of moderate to severe intermittent rhinitis and/or rhinoconjunctivitis during the grass season according to ARIA classification (28) 3.Symptoms more than 2 years prior to study start 4.Detectable specific IgE = 2 CAP RAST to grass pollen at the screening visit (V1) or within the previous 12 months 5.Positive skin‐prick test (wheal diameter of at least 3 mm > negative control; Phleum pollen, 30 HEPL/ml; Laboratorios LETI, S.L, Tres Cantos, Spain) Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range