The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With Asthma

Karolinska Institutet30 enrolled

Overview

The study evaluates the safety and efficacy of intralymphatic allergen-specific immunotherapy given to adolescents and young adults who are allergic to grass or birch pollen and have mild or moderate asthma. Patients will be treated with three intralymphatic injections; 1000 SQ-U x3 with 4-5 weeks interval, or placebo with 4-5 weeks interval. The patients receiving treatment will be given a fourth injection one year after the initial injections. The study is conducted in collaboration between Professor Lars Olof Cardell (ENT), prof Gunilla Hedlin (Pediatrics) and prof Marianne van Hage (Immunology)".

30 patients with seasonal allergic rhinitis due to birch or grass pollen are included. Study subjects are randomized to intralymphatic injections with placebo or ALK Alutard 5-grasses / birch or placebo. The patients receiving treatment will be given a fourth injection one year after the initial injections.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Rhinitis Asthma Allergy

Eligibility

Sex: ALLMin age: 16 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Allergic rhinitis due to grass or birch pollen * Mild to moderate asthma with a positive methacholine challenge * Accepted and signed informed consent. Exclusion Criteria: * Previously subcutaneous immunotherapy (SCIT) with total symptom relief. * Previously SCIT but no symptom improvement at all. * Sensitizations to house dust mite or furry animals, with ongoing exposure and symptoms. * Severe atopic dermatitis. * Patients with significant diseases other than allergic rhinitis. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study. * Patients with a respiratory tract infection in the past 4 weeks prior to Visit 2. * Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants). * Known autoimmune or collagen disease * Cardiovascular disease * Hepatic disease * Known renal insufficiency * Cancer * Hematologic disease * Chronic infectious disease * Any medication with a possible side-effect of interfering with the immune response * Previous immuno- or chemotherapy * Disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers) * Major metabolic disease * Known or suspected allergy to the study product * Obesity with BMI \> 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection. * Patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to Visit 1. * Patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to Visit 1. * Mental incapability of coping with the study * Withdrawal of informed consent

Outcomes

Primary Outcomes

Change in Symptoms Score After Nasal Allergen Challenge

0,1 ml of ALK Aquagen birch or timothy 10 000 SQU/ml is deposited in each nostril and allergy symptoms are recorded. Symptoms during NPTs were scored according to the Lebel scoring scale. Symtom scores at 5, 15, and 30 minutes after nasal administration of the allergenextract were summed to represent the symptom-score at each nasal challenge (at inclusion, 12 months after inclusion and for the active patients 24 months after inclusion). The scoring system identifies nasal, eye, and ear symptoms: rhinorrhea, nasal pruritus, nasal congestion, ocular pruritus, watery eyes, and itchy ears, each graded on a scale from 0 to 3 points, and a total score was summarized after subtracting the starting score (min score is 0 and maximum score is 54 + the number of sneezes). Higher scores mean worse outcome.