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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05191186
Other study ID # 2020-001060-28
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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