NCT04296474

Follow up Study 5-6 Years After ILIT With 2 Concomitant Allergens, Birch and Grass

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Lars Olaf Cardell · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

52 patients that had previously participated in the RDBPC study of intralymphatic immunotherapy (ILIT) with 2 concomitant allergens, birch and grass, with NCT02423707, were eligible for an open follow up 5-6 years after treatment.

Detailed description

Bakground: Intralymphatic immunotherapy has been proposed as a new, more effective, modality for allergy immunotherapy. With ultrasound- guided injections into the lymph node the allergen is injected directly to the secondary lymphoid organ to stimulate the immune system. The protocol that has been used so far is three injections with one month interval. The effect have been evaluated in several studies with limited sample sized and the effect have been estimated to be in the same range as after conventinal subcutaneous immunotherapy. No long term follow up have been performed. Objective: To investigate if the clinical improvement and immunological alterations is maintained 5-6 years after ILIT with two concomitant allergens, birch and grass. Methods: 52 patients that had previously participated in the RDBPC study were asked to participate in this open follow up.

Conditions

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	ALK Alutard 5-grasses and birch	Intralymphatic injections
DRUG	ALK Diluent	intralymphatic injections

Timeline

• Start date: 2018-05-15
• Primary completion: 2022-06-20
• Completion: 2022-07-01
• First posted: 2020-03-05
• Last updated: 2022-09-21

Locations

3 sites across 1 country: Sweden