Documentation of Efficacy of Intralymphatic Allergen Immunotherapy

Allergic Asthma Clinical Trial

— ILITNU  

Official title:

Documentation of Efficacy of Intralymphatic Allergen Immunotherapy in a Phase III Randomized, Parallel Group Placebo Controlled Double Blind Multisite Field Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05191186
• Other study ID #: 2020-001060-28
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 1, 2020
• Est. completion date: December 2023

Study information

• Verified date: January 2022
• Source: Aarhus University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 pollen allergic patients compared to placebo

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 pollen allergic subjects. Primary endpoint is the difference in combined symptom and medication score during grass pollen seasons following treatment compared with patients receiving placebo. Injections are giving ultrasound-guided with at least 4 weeks intervals.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: December 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• moderate-severe grass pollen allergic rhinoconjunctivitis
• positive skin prick test for grass pollen extract

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Allergic Asthma
• Allergic Rhinitis Due to Grass Pollen
• Conjunctivitis
• Conjunctivitis, Allergic
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• Grass pollen extract - Alutard Phleum pratense, ALK
injection in lymph node

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus	Central Region
Sweden	Lars University Ahlbeck	Linkoeping	Oestergotland

Sponsors (3)

Lead Sponsor	Collaborator
Aarhus University Hospital	University Hospital, Linkoeping, University of Aarhus

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Combined symptom and medication score, cSMS	daily combined symptom and medication scores during grass pollen seasons in 2022 and 2023 as compared to placebo.; cSMS is a combined score of a symptom score, 0-3, where 0 indicates no symptoms and 3 indicates severe symptoms and meddication score 0-3 according to the us of reliever medication: 0: no medication, 1: antihistamine use, 2: local steroid use, 3: systemic steroid use.; This results in a score ranging from 0 (no symptoms, no need for medications) to 6 (severe symptoms and need for maximum reliever medication	2 years
Secondary	side-effects	occurence of side-effects as compared to placebo	3 months
Secondary	correlation of CSMS to pollen count	correlate cSMS to daily pollen counts	2 years
Secondary	combined symptom and medication score, cSMS	change in the combined symptom and medication score from baseline	2 years
Secondary	Rhinitis related quality of life, RQLQ	changes on rhinitis related quality of life	2 years
Secondary	Airwave oscillometry system(AOS), asthma	Influence of ILIT on resistance in the lower airways measured by AOS	2 years

External Links

•   project homepage