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

ConditionAllergic Rhinitis Due to Grass Pollen
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorLars Olaf Cardell

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

informed consent

Disqualifiers

chronic rhinosinusitis with or without nose polyps

Previous immunotherapy (SLIT or SCIT)

BMI > 35

house dust mite allergy with symptoms

Trial design

Design model

Parallel

Treatments tested in this trial

  • SLIT Grazax ALK Nordic 75 000 SQ-T

    Drug

    Daily sublingual grass allergen tablets

  • ILIT + Vitamin D

    Drug

    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

  • ILIT + placebo

    Drug

    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

Treatment groups

360 Participants
are divided into 3 treatment groups
Group A: SLITActive comparator 1 intervention
Group B: ILIT + Vitamin DActive comparator 1 intervention
Group C: ILIT + placeboActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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.
2

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.
3

VAS (0-10)

Recalled symptoms severity at visual analogue scale

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lars Olaf Cardell

Lead sponsor

Karolinska Institutet

Sponsor institution

Source ClinicalTrials.gov
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