CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 32 enrolled
Drug / intervention
ILIT with extract of causal allergen +2 morebiological
Likely dose
ILIT with extract of causal allergen 0.5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02665754
NCT02665754Phase 1Completed

The Efficacy and Adverse Effect of Intralymphatic Immunotherapy With Tyrosine S®, Allergen Extract for Immunotherapy, in Patients With Allergic Rhinitis Induced by House Dust Mite, Dog, and Cat Allergen

Gachon University Gil Medical Center·interventional·Posted Jan 28, 2016·Updated Feb 11, 2020

In Brief

A Phase 1 clinical trial evaluating ILIT with extract of causal allergen, ILIT with normal saline, and 1 other intervention for Allergic Rhinitis. Completed, enrolled 32 participants across 1 site.

Detailed Summary

The investigators will perform double-blinded placebo-controlled randomized clinical trial which evaluates the efficacy and safety of allergen-specific intralymphatic immunotherapy (ILIT) for allergens including Dermatophagoides farinae (Df), Dermatophagoides pteronyssinus (Dp), cat, and dog that are sensitized and provoke rhinitis-related symptoms in patients with allergic rhinitis (AR), using allergen extracts for allergen-specific immunotherapy (Tyrosine S, Allergy Therapeutic, West Sussex, UK).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSouth Korea

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 28, 2016
Enrollment StartJul 1, 2016
Primary CompletionDec 1, 2019
Study CompletionJan 1, 2020
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.4 years ago

Interventions

ILIT with extract of causal allergenbiological

0.5 ml of allergen extract from D. farinae, D. pteronyssinus, cat, and/or dog for allergen specific immunotherapy (Tyrosine S, Allergy Therapeutic, UK) will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval.

ILIT with normal salinebiological

0.5 ml of normal saline will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval.

Rescue medication for allergic rhinitisdrug

Subjects are requested to administer oral antihistamine (cetirizine) or nasal glucocorticosteroid (ciclesonide) as rescue medication for allergic rhinitis in accordance with severity and frequency of allergic rhinitis symptoms according to Allergic Rhinitis and its Impact on Asthma (ARIA) guideline.