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

RecruitingPhase 2, Phase 3Ages 18 Years - 60 YearsAllLars Olaf Cardell
NCT06061848 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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alcohol abuse * intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1 * withdrawn consent Exclusion Criteria only for ILIT group (due to vitamin D treatment) * medication witch can interacts with vitD: (ACE-inhibitors, antiepileptic drugs,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)
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What it tests

  • SLIT Grazax ALK Nordic 75 000 SQ-T
  • ILIT + Vitamin D
  • ILIT + placebo
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Where

3 sites
Skåne University Hospital, ENT department
Lund, Sweden
Örebro University Hospital
Örebro, Sweden
Karolinska University Hospital, ENT-department
Stockholm, Sweden
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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