Clinical Trial: Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis Patients

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Double-blinded Placebo-controlled Randomized Clinical Trial Evaluating the Efficacy and Adverse Effect of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic <

Brief Summary: We 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.

Detailed Summary:

After informed consent, subjects will be randomly assigned to ILIT group or placebo group in double-blind manner. In both group, causal allergen or placebo will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. In ILIT group, initial dose of allergen will be 1,000-fold diluted solution from maximal concentration of allergen extract for subcutaneous immunotherapy (30 AU/ml for Df or Dp, 10 AU/ml for Cat hair, and 1:1/10 weight/volume for dog hair/dander, HollisterStier, New Orleans, USA) in volume of 0.1ml. If skin is highly reactive in skin prick test, the initial dose will be 10-fold dilution from maximal concentration where diameter of wheal is less than that of histamine. After the first dose, allergen concentration will be escalated 3-fold at second dose, and 10-fold at third dose if there are no local or systemic hypersensitivity reaction. The allergen concentration will not change at second or third dose if there is mild local or systemic reaction. The allergen concentration will decrease by 10 or 100-fold from previous concentration or further injection will be holded if there is severe local or systemic reaction after sufficient explanation and discussion with subjects.

The investigators will evaluate allergic rhinitis symptom score before and 4, 12 months after the initial treatment. Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Sino-Nasal Outcome Test (SNOT-20) will be used. Visual analogue scale (VAS) of symptoms including rhinorrhea, sneezing, nasal obstruction, postnasal drip, eye/nose/ear/palate itching, dyspnea, wheezing, chest discomfort as well as urticaria, angioedema, and itching on exposed skin during exposure to causal allergen in daily life will be also evaluated. Skin prick test, intradermal test, blood sampling for serum allergen-specific IgE, exhaled nitric oxide, and nasal la
Sponsor: Gachon University Gil Medical Center

Current Primary Outcome: Rhinoconjunctivitis Quality of Life Questionnaire [ Time Frame: up to 12 months after the initial treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • SNOT-20 [ Time Frame: before and 4, 12 months after the initial treatment ]
    Sino-Nasal Outcome Test
  • Skin reactivity [ Time Frame: before and 4, 12 months after the initial treatment ]
    Diameters of wheal provoked by causal allergens in skin prick test and intradermal test
  • Serum alllergen-specific IgE level [ Time Frame: before and 4, 12 months after the initial treatment ]
    Serum alllergen-specific IgE level using UNICAP, Thermofisher Scientific, Sweden
  • Nasal reactivity [ Time Frame: before and 4, 12 months after the initial treatment ]
    Threshold concentration in nasal provocation test for allergens of Df and Dp
  • Cytokines in nasal lavage fluid [ Time Frame: before and 4, 12 months after the initial treatment ]
    Cytokines of Th1, Th2, and Treg in nasal lavage fluid
  • Exhaled NO [ Time Frame: before and 4, 12 months after the initial treatment ]
    Exhaled nitric oxide measuring NIOX MINO, Thermofisher Scientific, Sweden
  • Allergic rhinitis symptoms during allergen exposure in daily life [ Time Frame: before and 4, 12 months after the initial treatment ]
    Visual analog scare of allergic rhinitis symptoms during allergen exposure in daily life


Original Secondary Outcome: Same as current

Information By: Gachon University Gil Medical Center

Dates:
Date Received: October 17, 2014
Date Started: August 2014
Date Completion:
Last Updated: August 10, 2016
Last Verified: August 2016