Status:
COMPLETED
The Safety and Efficacy of Intralymphatic Immunotherapy in Pollen Allergic Adolescents and Young Adults With Asthma
Lead Sponsor:
Karolinska Institutet
Conditions:
Rhinitis
Asthma
Eligibility:
All Genders
16-50 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
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 place...
Eligibility Criteria
Inclusion
- Allergic rhinitis due to grass or birch pollen
- Mild to moderate asthma with a positive methacholine challenge
- Accepted and signed informed consent.
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03394508
Start Date
January 1 2013
End Date
December 1 2017
Last Update
September 28 2020
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