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

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Biological: Allergen extract Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-labeled Pilot Study of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis Patients
Study Start Date : November 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : March 2015
Arms and Interventions
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Arm Intervention/treatment
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

 Biological: Allergen extract
Causal allergen extract such as D. farinae, D. pteronyssinus, cat hair, dog hair/dander, or combination of those


Outcome Measures
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Primary Outcome Measures :
  1. RQLQ [ Time Frame: Baseline and 4 months after the first injection ]
    Rhinoconjunctivitis Quality of Life Questionnaire


Secondary Outcome Measures :
  1. SNOT-20 [ Time Frame: Baseline and 4 months after the first injection ]
    Sino-Nasal Outcome Test-20

  2. 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

  3. 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

  4. 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

  5. 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

  6. Exhaled NO [ Time Frame: Baseline and 4 months after the first injection ]
    Exhaled nitric oxide measuring NIOX MINO, Thermofisher Scientific, Sweden

  7. 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)


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 (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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301884


Locations
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Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center
Thermo Fisher Scientific
Investigators
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Principal Investigator: Sang Min Lee, M.D., Ph.D. Gachon University Gil Medical Center
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Sang Min Lee, Assistant professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT02301884    
Other Study ID Numbers: GBIRB2013-35
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: March 11, 2015
Last Verified: March 2015
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
 Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases