Allergic Rhinitis Clinical Trial
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 Rhinitis Patients
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.
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 lavage for Th1, Th2, and Treg cytokines will be also performed
before and 4, 12 months after the initial treatment.
Adverse events will be recorded and graded according to Muller classification and Ring and
Messner classification.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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