The efficacy and adverse effect of intralymphatic immunotherapy (ILIT) for allergic diseases

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0001534

Enrollment

144

Registered

2015-06-24

Start date

2014-09-04

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 - 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 (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 allergen specific IgE level;Levels of IL-4, IFN-g, and IL-10 cytokines in nasal lavage fluid	—

Countries

Korea, Republic of

Contacts

Public ContactSang Min Lee

Gachon University Gil Medical Center

Outcome results