Allergic Rhinitis
Conditions
Keywords
allergic rhinitis, immunotherapy
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 description
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.
Interventions
DRUGHollisterStier
0.1 ml of 30 AU/ml for Df or Dp, 10 AU/ml for Cat hair, and/or 1:1/10 weight/volume for dog hair/dander 3 injections into an inguinal lymph node
DRUGNormal saline
0.1 ml of normal saline 3 injections into an inguinal lymph node
Sponsors
Thermo Fisher Scientific, Inc
Gachon University Gil Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Allergic rhinitis to house dust mite (Df, Dp), cat or dog * More than 3mm reaction at skin prick test for Df, Dp, cat or dog or more than class 3 at serum specific IgE level (UNICAP or MAST)
Exclusion criteria
* Uncontrolled or severe asthma according to Global Initiative of Asthma (GINA) guideline * FEV1 less than 50% of predicted value if there is comorbid asthma. * Subject rejects the enrollment into study * Low compliance * Pregnancy or lactation * Significant cardiovascular, hepatic, renal, hematologic, oncologic, or infectious diseases * Administration of beta blocker, angiotensin converting enzyme inhibitor, tricyclic antidepressant, immnosuppressant including systemic glucocorticosteroid (20mg or more dose of prednisolone or equivalent dose of other steroid) within last 2 weeks * Prior history of allergen-specific immunotherapy * Allergic rhinitis caused by other perennial or seasonal allergen * Vulnerable volunteer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rhinoconjunctivitis Quality of Life Questionnaire | up to 12 months after the initial treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Skin reactivity | 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 | before and 4, 12 months after the initial treatment | Serum alllergen-specific IgE level using UNICAP, Thermofisher Scientific, Sweden |
| Nasal reactivity | before and 4, 12 months after the initial treatment | Threshold concentration in nasal provocation test for allergens of Df and Dp |
| SNOT-20 | before and 4, 12 months after the initial treatment | Sino-Nasal Outcome Test |
| Exhaled NO | 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 | before and 4, 12 months after the initial treatment | Visual analog scare of allergic rhinitis symptoms during allergen exposure in daily life |
| Cytokines in nasal lavage fluid | before and 4, 12 months after the initial treatment | Cytokines of Th1, Th2, and Treg in nasal lavage fluid |
Countries
South Korea
Outcome results
None listed