Status:
COMPLETED
Documentation of Efficacy of Intralymphatic Allergen Immunotherapy
Lead Sponsor:
Aarhus University Hospital
Collaborating Sponsors:
University of Aarhus
University Hospital, Linkoeping
Conditions:
Allergic Rhinitis Due to Grass Pollen
Allergic Conjunctivitis of Both Eyes
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
Investigation of the clinical efficacy of 3 intralymphatic injections with grass pollen extract into inguinal lymph nodes on combined symptom-medication scores during grass pollen season in grass poll...
Detailed Description
A double-blind, parallel group, placebo controlled multi-site trial of the clinical efficacy of 3 intralymphatic injections with a low dose of grass pollen extract into inguinal lymph nodes in grass p...
Eligibility Criteria
Inclusion
- moderate-severe grass pollen allergic rhinoconjunctivitis
- positive skin prick test for grass pollen extract
Exclusion
- significant mugwort allergy
- previous AIT for grass pollen allergy
- uncontrolled non-allergic upper airways disease
- uncontrolled asthma
- planned depot steroid injections during season
- uncontrolled autoimmune diseases
- active malignancies
- uncontrolled other severe condition, including psychiatric diseases
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
450 Patients enrolled
Trial Details
Trial ID
NCT05191186
Start Date
February 1 2020
End Date
December 31 2023
Last Update
August 12 2025
Active Locations (2)
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1
Aarhus University Hospital
Aarhus, Central Region, Denmark, 8200
2
Linkoeping University Hospital
Linköping, Oestergotland, Sweden, 58183