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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-15

Study Completion Date

2022-07-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active ILIT treated

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

Group Type ACTIVE_COMPARATOR

ALK Alutard 5-grasses and birch

Intervention Type DRUG

Intralymphatic injections

Non- AIT treated

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).

Group Type PLACEBO_COMPARATOR

ALK Diluent

Intervention Type DRUG

intralymphatic injections

Interventions

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ALK Alutard 5-grasses and birch

Intralymphatic injections

Intervention Type DRUG

ALK Diluent

intralymphatic injections

Intervention Type DRUG

Other Intervention Names

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Grass and birch allergen with aluminum adjuvant Human albumin

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No