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

Last updated: October 17, 2024
Sponsor: Lars Olaf Cardell
Overall Status: Active - Recruiting

Phase

2/3

Condition

Nasal Obstruction

Allergy

Common Cold

Treatment

ILIT + Vitamin D

SLIT Grazax ALK Nordic 75 000 SQ-T

ILIT + placebo

Clinical Study ID

NCT06061848
Dnr KS: K2021-5840
  • Ages 18-60
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

  • informed consent

Exclusion

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 atthe 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  • withdrawn consent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)

Study Design

Total Participants: 360
Treatment Group(s): 3
Primary Treatment: ILIT + Vitamin D
Phase: 2/3
Study Start date:
February 01, 2023
Estimated Completion Date:
December 28, 2031

Connect with a study center

  • Skåne University Hospital, ENT department

    Lund,
    Sweden

    Site Not Available

  • Karolinska University Hospital, ENT-department

    Stockholm,
    Sweden

    Active - Recruiting

  • Örebro University Hospital

    Örebro,
    Sweden

    Site Not Available

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