Intralymphatic Immunotherapy Enhanced by Vitamin-D, a Randomized Placebo-controlled Trial and Comparison With SLIT
Lars Olaf Cardell
360 participants
Feb 1, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria2
- moderate to severe allergic rhinitis due to grass pollen, with Rhinitis Total Symptom Score >/= 8.
- informed consent
Exclusion Criteria35
- 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
- (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- withdrawn consent
- 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)
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Interventions
Daily sublingual grass allergen tablets
1 mL of Vicotrat D3, Heyl Pharma, 100 000 IU/mL, as intramuscular injection. Followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U/mL as three intralymphatic injections
1 ml of Sodium chloride solution 9 mg/mL as intramuscular injection followed by 0,1 mL of Alutard SQ timothy, ALK Nordic, 10 000 SQ-U/mL as three intralymphatic injections
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06061848