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

August 10, 2016 updated by: Sang Min Lee, Gachon University Gil Medical Center

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Allergen extract
0.1 ml of allergen extracts
Drug: HollisterStier
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
Other Names:
  • Allergen extracts, New Orleans, USA
Placebo Comparator: Placebo
Normal saline, 0.1 ml
Drug: Normal saline
0.1 ml of normal saline 3 injections into an inguinal lymph node
Other Names:
  • JW-pharma, Seoul, Republic of Korea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rhinoconjunctivitis Quality of Life Questionnaire
Time Frame: up to 12 months after the initial treatment
up to 12 months after the initial treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SNOT-20
Time Frame: before and 4, 12 months after the initial treatment
Sino-Nasal Outcome Test
before and 4, 12 months after the initial treatment
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
before and 4, 12 months after the initial treatment
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
before and 4, 12 months after the initial treatment
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
before and 4, 12 months after the initial treatment
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
before and 4, 12 months after the initial treatment
Exhaled NO
Time Frame: before and 4, 12 months after the initial treatment
Exhaled nitric oxide measuring NIOX MINO, Thermofisher Scientific, Sweden
before and 4, 12 months after the initial treatment
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
before and 4, 12 months after the initial treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Collaborators

Thermo Fisher Scientific, Inc

Investigators

  • Principal Investigator: Sang Min Lee, M.D., Ph.D., Gachon University Gil Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

October 17, 2014

First Submitted That Met QC Criteria

October 20, 2014

First Posted (Estimate)

October 21, 2014

Study Record Updates

Last Update Posted (Estimate)

August 11, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140101480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Allergic Rhinitis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe