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

Phase 3RecruitingNCT06061848

Lars Olaf Cardell360 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

360

Conditions

Allergic Rhinitis Due to Grass Pollen

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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alcohol abuse * intake of other study product within 1 month or 6 half times, which ever is longest, before visit 1 * withdrawn consent Exclusion Criteria only for ILIT group (due to vitamin D treatment) * medication witch can interacts with vitD: (ACE-inhibitors, antiepileptic drugs,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

Locations (3)

Skåne University Hospital, ENT department

Lund, Sweden

NOT_YET_RECRUITING

Örebro University Hospital

Örebro, Sweden

NOT_YET_RECRUITING

Karolinska University Hospital, ENT-department

Stockholm, Sweden

RECRUITING

Outcomes

Primary Outcomes

CSMS

Daily Combined Symptoms and Medication Scores (0-3)

Time frame: 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.

Secondary Outcomes

CSMS peak pollen season

Daily Combined Symptoms and Medication Scores (0-3) during the 15 consecutive days with the highest pollen count

Time frame: 15 days at the grass pollen season year 1; 4 months before treatment. 15 days year 2; 6 months after start of treatment.

RQLQ

Juniper Rhinoconjunctivitis Quality of Life Questionnaire, weekly scores (0-28)

Time frame: 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)

Recalled symptoms severity at visual analogue scale

Time frame: 4-6 months before treatment and 6-9 months after treatment

Serolology with immunoglobulins

Total and grass specific levels of IgE, IgG, IgG4, IgA in serum

Time frame: 1 year before treatment, 4-6 weeks after treatment, 1 year after treatment