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Keep this study
Lead
Karolinska Institutet
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.
Age
16–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Allergic rhinitis due to grass or birch pollen
Mild to moderate asthma with a positive methacholine challenge
Accepted and signed informed consent.
You may not be if
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
Clareo Health | The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With Asthma
