Intralymphatic immunotherapy with Tyrosine S®, allergen extract for immunotherapy

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001777

Enrollment

Registered

2016-01-15

Start date

2016-07-13

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : Subjects will be randomly assigned to active or placebo group in double-blinded manner. Then, causal allergen extract (active group) or normal saline (placebo) wi

Eligibility

Sex/Gender

All

Inclusion criteria

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 (ImmunoCAP® or multiple allergosorbent test)

Exclusion criteria

Exclusion criteria: - Uncontrolled or severe asthma according to Global Initiative of Asthma (GINA) guideline - Forced expiratory volume in 1 second (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 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 (RQLQ)	—

Secondary

Measure	Time frame
Sino-Nasal outcome Test (SNOT-20) ;Allergen wheal diameter in skin prick test and intradermal test ;cut-off point of concentration in nasal provocation test for D. farinae and D. pteronyssinus ;Serum total IgE level;Serum allergen specific IgE and IgG4 level ;Levels of IL-4, IL-5, IL-10, IL-12, IL-13, IFN-g, and TGF-b cytokines in nasal lavage fluid ;Cell count of inflammatory cell in nasal mucosa;Subjects' recognition of causal allergens, their avoidance, and allergen-specific immunotherapy;Subjects' willingness to pay for allergen avoidance, and allergen-specific immunotherapy;Local or systemic adverse reaction during intralymphatic immunotherapy;Expression of CD 63 on cell membrane of peripheral blood basophil during stimulation with causal allergen	—

Measure

Time frame

Sino-Nasal outcome Test (SNOT-20) ;Allergen wheal diameter in skin prick test and intradermal test ;cut-off point of concentration in nasal provocation test for D. farinae and D. pteronyssinus ;Serum total IgE level;Serum allergen specific IgE and IgG4 level ;Levels of IL-4, IL-5, IL-10, IL-12, IL-13, IFN-g, and TGF-b cytokines in nasal lavage fluid ;Cell count of inflammatory cell in nasal mucosa;Subjects' recognition of causal allergens, their avoidance, and allergen-specific immunotherapy;Subjects' willingness to pay for allergen avoidance, and allergen-specific immunotherapy;Local or systemic adverse reaction during intralymphatic immunotherapy;Expression of CD 63 on cell membrane of peripheral blood basophil during stimulation with causal allergen

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Countries

Korea, Republic of

Contacts

Public ContactSang Min Lee

Gachon University Gil Medical Center

sangminlee77@naver.com+82-32-460-2634

Outcome results