Follow up Study 5-6 Years After ILIT With 2 Concomitant Allergens, Birch and Grass

Lars Olaf Cardell

Status and phase: Completed; Phase 2; Phase 1

Conditions: Allergic Rhinitis

Treatments: Drug: ALK Alutard 5-grasses and birch; Drug: ALK Diluent

Study type: Interventional

Funder types: Other

Identifiers

NCT04296474

Follow-up ILIT 2018/2645-32

Details and patient eligibility

About

52 patients that had previously participated in the RDBPC study of intralymphatic immunotherapy (ILIT) with 2 concomitant allergens, birch and grass, with NCT02423707, were eligible for an open follow up 5-6 years after treatment.

Full description

Bakground: Intralymphatic immunotherapy has been proposed as a new, more effective, modality for allergy immunotherapy. With ultrasound- guided injections into the lymph node the allergen is injected directly to the secondary lymphoid organ to stimulate the immune system. The protocol that has been used so far is three injections with one month interval. The effect have been evaluated in several studies with limited sample sized and the effect have been estimated to be in the same range as after conventinal subcutaneous immunotherapy. No long term follow up have been performed.

Objective: To investigate if the clinical improvement and immunological alterations is maintained 5-6 years after ILIT with two concomitant allergens, birch and grass.

Methods: 52 patients that had previously participated in the RDBPC study were asked to participate in this open follow up.

Enrollment: 34 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe allergic rhinitis to birch and grass pollen defined with a positive skin prick test and elevated allergen specific IgE antibodies

Exclusion criteria

• uncontrolled or perennial asthma
• other pulmonary disease
• known autoimmune or collagen disease
• chronic infection
• other significant disease
• severe atopic dermatitis
• use of beta blockers or angiotensin converting enzyme inhibitors as antihypertensive medications
• symptomatic sensitization to house dust mite or furry animals with daily exposure
• chronic upper airways disease
• pregnancy
• nursing
• obesity with BMI >30
• withdrawn informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups, including a placebo group

Active ILIT treated

Active Comparator group

Description:

Patients that have received ILIT with birch and grass allergen 5-6 years previously

Treatment:

Drug: ALK Alutard 5-grasses and birch

Non- AIT treated

Placebo Comparator group

Description:

Patients that have received placebo ILIT 5-6 years previously and patients with birch and grass pollen induced allergic rhinitis that have not previously been treated with allergen immunotherapy (AIT).

Treatment:

Drug: ALK Diluent