Is Intralymphatic Allergen Immunotherapy effective and safe: a human randomized clinical trial - Intralympatic ASIT

INTERVENTION: Trade Name: ALK‐alutard SQ betulla Verrucosa Product Name: ALK‐alutard SQ Betula verrucosa Pharmaceutical Form: Injection CAS Number: 8000045252 Other descriptive name: ALLERGENS, POLLEN & PLANT EXTRACT Concentration unit: SQU/ml Standardised Quality Unit(s)/millilitre (Deprecated) Concentration type: equal Concentration number: 100000‐ Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intralymphatic use Trade Name: ALK‐alutard 5‐grass Product Name: ALK Alutard 5‐grass Pharmaceutical Form: Injection CAS Number: 8000045252 Other descriptive name: ALLERGENS, POLLEN & PLANT EXTRACT Concentration unit: SQU/ml Standardised Quality Unit(s)/millilitre (Deprecated) Concentration type: equal Concentration number: 100000‐ Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Intralymphatic use CONDITION: Seasonal Allergic rhinitis due to pollen from grass and betula verrucosa PRIMARY OUTCOME: Main Objective: Allergen immunotherapy is succesful in the treatment of hypersensitivity to a wide range of allergens. Allergen immunotherapy affects the long‐term development of allergic rhinits and asthma. Currently the mode of allergen immunotherapy is very exhausting, time consuming and expensive for the patient and for health planners and implies regular patient visits for a period of 3‐5 years. Emerging evidence shows that direct intralymphatic injection yields a faster beneficial result with a 1000‐fold lower dose which will reduce both the dose necessary and the number of clinic visits associated with the treatment. The study objective is to evaluate if intralymphatic allergen specific immunotherapy (il‐ASIT) can be an effective and safe way to alleviate seasonal symptoms of grass pollen induced allergic rhinitis. The Primary outcome measure is the effect on subjective symptoms following nasal allergen provocation two months after the end of the first season. Primary end point(s): The Primary outcome measures is the effect on subjective symptoms following nasal allergen provocation two months after the end of the first season. An active il‐ASIT group will be compared to a placebo il‐ASIT group and a group that has been treated with traditional pharmaca during the season. ; Secondary Objective: Secondary outcome measures are: ; ‐ Safety parameter: registration of adverse events from the time of the first injection to 30 days after last injection.; ‐ Effects on quality of life measured during the first season using the SF‐36 Health Survey (all three groups).; ‐ Evaluation of medicine ; ‐ Skin prick reactions and inflammatory mediators in blood ; ‐ Nasal provocations with grass pollen followed by blood sampling and nasal lavage will be performed out of season ; INCLUSION CRITERIA: ‐ Age 18‐65, ‐ Seasonal allergic symptoms for grass verified by skin prick test, ‐ Accepted informed consent. Are the trial subjects under 18? no 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) no F.1.3.1 Number of subjects for this age range