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

Обзор

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.

Вмешательства

• Препарат SLIT Grazax ALK Nordic 75 000 SQ-T
  Daily sublingual grass allergen tablets
• Препарат ILIT + Vitamin D
  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
• Препарат ILIT + placebo
  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

Первичные конечные точки

• CSMS [Срок оценки: 60-75 days at the grass pollen season year 1; 4 months before treatment. 60-75 days year 2; 6 months after start of treatment.]

Вторичные конечные точки (4)

• CSMS peak pollen season [Срок оценки: 15 days at the grass pollen season year 1; 4 months before treatment. 15 days year 2; 6 months after start of treatment.]
• RQLQ [Срок оценки: 60-75 days at the grass pollen season year 1; 4 months before treatment. 60-75 days year 2; 6 months after start of treatment.]
• VAS (0-10) [Срок оценки: 4-6 months before treatment and 6-9 months after treatment]
• Serolology with immunoglobulins [Срок оценки: 1 year before treatment, 4-6 weeks after treatment, 1 year after treatment]

Критерии участия

Критерии включения

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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Швеция · 3 центра

• Skåne University Hospital, ENT department — Lund
• Örebro University Hospital — Örebro
• Karolinska University Hospital, ENT-department — Stockholm

Идентификаторы

NCT: NCT06061848 · Dnr KS: K2021-5840

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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