Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT

• Status: Recruiting
• Trial end date: 2031-12-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lars Olaf Cardell
• Treatments: Vitamin D

Criteria

Inclusion Criteria:

• moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score >/= 8.

• informed consent

Exclusion Criteria:

• chronic rhinosinusitis

• Previous immunotherapy

• BMI > 35

• house dust mite allergy with symptoms or allergy towards furry animals with exposition

• 25(OH)Vitamin D levels < 25 or > 75 nmol/L

• 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

• medication with antiepileptic drugs, glykosides, orlistat, statines, thiazide diuretics

• Mb Paget, osteoporosis or sarcidosis

• Hyperparathyroidism or other disease conferring risk of hypercalcemia

• malabsorption or bowel disease with diarrea

• tendency for formation of kidney stones

• hereditary pseudohypoparathyroidism with decreased phosphorous secretion

• use of Vitamin D supplementation or excessive use of sun tanning booths

• drug abuse

• intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1

• Mental incapacity to follow study protocol

• withdrawn consent

• other significant disease

• allergy towards study medication