Overview
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
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 medication cannot be paused at the day for treatment
- drug or alcohol abuse
- intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1
- withdrawn consent
Exclusion Criteria only for ILIT group (due to vitamin D treatment)
- medication witch can interacts with vitD: (ACE-inhibitors, antiepileptic drugs, glycosides, orlistat, statines, thiazide diuretics)
- tendency for formation of kidney stones
- hyperparathyroidism or other disease conferring risk of hypercalcemia
- hereditary pseudohypoparathyroidism with decreased phosphorous secretion
- malabsorption or bowel disease with diarrhea
- Mb Paget, osteoporosis or sarcoidosis
- skin disease at the groin (where the treatment will be injected)
