Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
Trial Parameters
Brief Summary
A national, multicenter, randmised double blind study with parallell arms. 360 patients with grass induced allergic rhinitis will be open randomised 1:2 to 3 years Grazax sublingual immunotherapy or 3 intralymphatic injections with ALK Alutard Timothy. In a second step, the ILIT group will be double blind randomised 1:1 to an intramuscular injection of Vitamin D Vicotrat or placebo, 4 week before the start of the intralymphatic treatment. The primary outcome measure is daily combined symptoms and medication scores during grass pollen season.
Eligibility Criteria
Inclusion Criteria: * moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score \>/= 8. * informed consent Exclusion Criteria: * chronic rhinosinusitis with or without nose polyps * Previous immunotherapy (SLIT or SCIT) * BMI \> 35 * house dust mite allergy with symptoms * allergy towards furry animals if exposition cannot be avoided * 25(OH)Vitamin D levels \< 25 or \> 75 nmol/L * use of Vitamin D supplementation or excessive use of sun tanning booths * mental incapacity to follow study protocol * other significant disease * allergy towards study medication * uncontrolled asthma * severe atopic dermatitis * pregnancy or nursing * autoimmune disease * hyper IgE-syndrome * cardiovascular disease * lung disease * liver or kidney disease * hematologic disorder * metabolic disease * chronic infectious disese * medications interacting with the immune system * cancer * previous cytostatic therapy * medication with beta-blockers or ACE-inhibiters, if medicati