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Pilot Study of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis (pILIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02301884
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : March 11, 2015
Sponsor:
Collaborator:
Thermo Fisher Scientific
Information provided by (Responsible Party):
Sang Min Lee, Gachon University Gil Medical Center

Tracking Information
First Submitted Date  ICMJE November 24, 2014
First Posted Date  ICMJE November 26, 2014
Last Update Posted Date March 11, 2015
Study Start Date  ICMJE November 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
RQLQ [ Time Frame: Baseline and 4 months after the first injection ]
Rhinoconjunctivitis Quality of Life Questionnaire
Original Primary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
RQLQ [ Time Frame: before and 4 months after the first injection ]
Rhinoconjunctivitis Quality of Life Questionnaire
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
  • SNOT-20 [ Time Frame: Baseline and 4 months after the first injection ]
    Sino-Nasal Outcome Test-20
  • Skin reactivity [ Time Frame: Baseline and 4 months after the first injection ]
    Allergen/histamine ratio of mean wheal diameter in skin prick test, and allergen/saline ratio of mean wheal diameter in intradermal test
  • Serum total and allergen-specific IgE and IgG4 level [ Time Frame: Baseline and 4 months after the first injection ]
    Serum total and allergen-specific IgE and IgG4 level using UNICAP, Thermofisher Scientific, Sweden
  • Nasal reactivity [ Time Frame: Baseline and 4 months after the first injection ]
    Symptom score and volume 2-6 cm in acoustic rhinometry during nasal provocation test with D. farinae and/or D. pteronyssinus in allergic rhinitis patients sensitized to house dust mite
  • Cytokines in nasal lavage fluid [ Time Frame: Baseline and 4 months after the first injection ]
    Cytokines of Th1, Th2, and Treg in nasal lavage fluid
  • Exhaled NO [ Time Frame: Baseline and 4 months after the first injection ]
    Exhaled nitric oxide measuring NIOX MINO, Thermofisher Scientific, Sweden
  • Respiratory and dermatologic symptoms provoked by allergen exposure in daily life [ Time Frame: Baseline and 4 months after the first injection ]
    Visual analogue scale of respiratory and dermatologic symptoms provoked by allergen exposure in daily life (ranged from 0 to 100)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2014)
  • SNOT-20 [ Time Frame: before and 4 months after the first injection ]
    Sino-Nasal Outcome Test-20
  • Skin reactivity [ Time Frame: before and 4 months after the first injection ]
    Allergen/histamine ratio of mean wheal diameter in skin prick test, and allergen/saline ratio of mean wheal diameter in intradermal test
  • Serum total and alllergen-specific IgE and IgG4 level [ Time Frame: before and 4 months after the first injection ]
    Serum total and alllergen-specific IgE and IgG4 level using UNICAP, Thermofisher Scientific, Sweden
  • Nasal reactivity [ Time Frame: before and 4 months after the first injection ]
    Symptom score and volume 2-6 cm in acoustic rhinometry during nasal provocation test with D. farinae and/or D. pteronyssinus in allergic rhinitis patients sensitized to house dust mite
  • Cytokines in nasal lavage fluid [ Time Frame: before and 4 months after the first injection ]
    Cytokines of Th1, Th2, and Treg in nasal lavage fluid
  • Exhaled NO [ Time Frame: before and 4 months after the first injection ]
    Exhaled nitric oxide measuring NIOX MINO, Thermofisher Scientific, Sweden
  • Respiratory and dermatologic symptoms provoked by allergen exposure in daily life [ Time Frame: before and 4 months after the first injection ]
    Visual analogue scale of respiratory and dermatologic symptoms provoked by allergen exposure in daily life (ranged from 0 to 100)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis
Official Title  ICMJE Open-labeled Pilot Study of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis Patients
Brief Summary The investigators performed open-labeled pilot study 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, causal allergen was injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval. Initial dose of allergen was 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. After the first dose, allergen concentration was escalated 3-fold at second dose, and 10-fold at third dose if there was no or mild local or systemic hypersensitivity reaction. The allergen concentration did not change at second or third dose if there was moderate local or systemic reaction. The allergen concentration was decreased by 10 or 100-fold from previous concentration if there was severe local or systemic reaction.

The investigators evaluated parameters regarding allergic rhinitis within a week before the first injection and 4 months after the first injection. These parameters included Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) and Sino-Nasal Outcome Test (SNOT-20), and 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. Skin prick test, intradermal test, blood sampling for serum allergen-specific IgE, exhaled nitric oxide, and nasal lavage for Th1, Th2, and Treg cytokines were also included. Adverse events were recorded and graded according to Muller's classification and Ring and Messmer's classification.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Allergic Rhinitis
Intervention  ICMJE Biological: Allergen extract
Causal allergen extract such as D. farinae, D. pteronyssinus, cat hair, dog hair/dander, or combination of those
Study Arms  ICMJE Experimental: Allergen extract

Causal allergen such as D. farinae (30 AU/ml), D. pteronyssinus (30 AU/ml), cat hair (10 AU/ml), dog hair/dander (1:1/10 w/v), or combination of those.

Allergen extract, HollisterStier, New Orleans, USA. Intralymphatic injection in volume of 0.1 ml, three times with 4-week interval. Concentration was increased, decreased, or unchanged at 2nd or 3rd injection according to local or systemic reaction after previous injection

Intervention: Biological: Allergen extract
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 25, 2014)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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, immunosuppressant 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02301884
Other Study ID Numbers  ICMJE GBIRB2013-35
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sang Min Lee, Gachon University Gil Medical Center
Study Sponsor  ICMJE Gachon University Gil Medical Center
Collaborators  ICMJE Thermo Fisher Scientific
Investigators  ICMJE
Principal Investigator: Sang Min Lee, M.D., Ph.D. Gachon University Gil Medical Center
PRS Account Gachon University Gil Medical Center
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP