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

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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)".

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Karolinska Institutet

Criteria

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