Pilot Study of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis (pILIT)
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Allergen extract
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility 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
Sites / Locations
- Gachon University Gil Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allergen extract
Arm Description
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
Outcomes
Primary Outcome Measures
RQLQ
Rhinoconjunctivitis Quality of Life Questionnaire
Secondary Outcome Measures
SNOT-20
Sino-Nasal Outcome Test-20
Skin reactivity
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
Serum total and allergen-specific IgE and IgG4 level using UNICAP, Thermofisher Scientific, Sweden
Nasal reactivity
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
Cytokines of Th1, Th2, and Treg in nasal lavage fluid
Exhaled NO
Exhaled nitric oxide measuring NIOX MINO, Thermofisher Scientific, Sweden
Respiratory and dermatologic symptoms provoked by allergen exposure in daily life
Visual analogue scale of respiratory and dermatologic symptoms provoked by allergen exposure in daily life (ranged from 0 to 100)
Full Information
NCT ID
NCT02301884
First Posted
November 24, 2014
Last Updated
March 10, 2015
Sponsor
Gachon University Gil Medical Center
Collaborators
Thermo Fisher Scientific, Inc
1. Study Identification
Unique Protocol Identification Number
NCT02301884
Brief Title
Pilot Study of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis
Acronym
pILIT
Official Title
Open-labeled Pilot Study of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center
Collaborators
Thermo Fisher Scientific, Inc
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Allergen extract
Arm Type
Experimental
Arm Description
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 Type
Biological
Intervention Name(s)
Allergen extract
Intervention Description
Causal allergen extract such as D. farinae, D. pteronyssinus, cat hair, dog hair/dander, or combination of those
Primary Outcome Measure Information:
Title
RQLQ
Description
Rhinoconjunctivitis Quality of Life Questionnaire
Time Frame
Baseline and 4 months after the first injection
Secondary Outcome Measure Information:
Title
SNOT-20
Description
Sino-Nasal Outcome Test-20
Time Frame
Baseline and 4 months after the first injection
Title
Skin reactivity
Description
Allergen/histamine ratio of mean wheal diameter in skin prick test, and allergen/saline ratio of mean wheal diameter in intradermal test
Time Frame
Baseline and 4 months after the first injection
Title
Serum total and allergen-specific IgE and IgG4 level
Description
Serum total and allergen-specific IgE and IgG4 level using UNICAP, Thermofisher Scientific, Sweden
Time Frame
Baseline and 4 months after the first injection
Title
Nasal reactivity
Description
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
Time Frame
Baseline and 4 months after the first injection
Title
Cytokines in nasal lavage fluid
Description
Cytokines of Th1, Th2, and Treg in nasal lavage fluid
Time Frame
Baseline and 4 months after the first injection
Title
Exhaled NO
Description
Exhaled nitric oxide measuring NIOX MINO, Thermofisher Scientific, Sweden
Time Frame
Baseline and 4 months after the first injection
Title
Respiratory and dermatologic symptoms provoked by allergen exposure in daily life
Description
Visual analogue scale of respiratory and dermatologic symptoms provoked by allergen exposure in daily life (ranged from 0 to 100)
Time Frame
Baseline and 4 months after the first injection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang Min Lee, M.D., Ph.D.
Organizational Affiliation
Gachon University Gil Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
24934402
Citation
Zaleska A, Eiwegger T, Soyer O, van de Veen W, Rhyner C, Soyka MB, Bekpen C, Demiroz D, Treis A, Sollner S, Palomares O, Kwok WW, Rose H, Senti G, Kundig TM, Ozoren N, Jutel M, Akdis CA, Crameri R, Akdis M. Immune regulation by intralymphatic immunotherapy with modular allergen translocation MAT vaccine. Allergy. 2014 Sep;69(9):1162-70. doi: 10.1111/all.12461. Epub 2014 Jul 12. Erratum In: Allergy. 2016 Jan;71(1):129.
Results Reference
background
PubMed Identifier
24439076
Citation
Kundig TM, Johansen P, Bachmann MF, Cardell LO, Senti G. Intralymphatic immunotherapy: time interval between injections is essential. J Allergy Clin Immunol. 2014 Mar;133(3):930-1. doi: 10.1016/j.jaci.2013.11.036. Epub 2014 Jan 15. No abstract available.
Results Reference
result
PubMed Identifier
24035151
Citation
Witten M, Malling HJ, Blom L, Poulsen BC, Poulsen LK. Is intralymphatic immunotherapy ready for clinical use in patients with grass pollen allergy? J Allergy Clin Immunol. 2013 Nov;132(5):1248-1252.e5. doi: 10.1016/j.jaci.2013.07.033. Epub 2013 Sep 13. No abstract available.
Results Reference
result
PubMed Identifier
22464647
Citation
Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Gronlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kundig TM. Intralymphatic immunotherapy for cat allergy induces tolerance after only 3 injections. J Allergy Clin Immunol. 2012 May;129(5):1290-6. doi: 10.1016/j.jaci.2012.02.026. Epub 2012 Mar 30.
Results Reference
result
PubMed Identifier
21725898
Citation
Senti G, Johansen P, Kundig TM. Intralymphatic immunotherapy: from the rationale to human applications. Curr Top Microbiol Immunol. 2011;352:71-84. doi: 10.1007/82_2011_133.
Results Reference
result
PubMed Identifier
19680119
Citation
Senti G, Johansen P, Kundig TM. Intralymphatic immunotherapy. Curr Opin Allergy Clin Immunol. 2009 Dec;9(6):537-43. doi: 10.1097/ACI.0b013e3283310ff7.
Results Reference
result
PubMed Identifier
19001265
Citation
Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wuthrich B, Crameri R, Graf N, Johansen P, Kundig TM. Intralymphatic allergen administration renders specific immunotherapy faster and safer: a randomized controlled trial. Proc Natl Acad Sci U S A. 2008 Nov 18;105(46):17908-12. doi: 10.1073/pnas.0803725105. Epub 2008 Nov 10.
Results Reference
result
PubMed Identifier
23374268
Citation
Hylander T, Latif L, Petersson-Westin U, Cardell LO. Intralymphatic allergen-specific immunotherapy: an effective and safe alternative treatment route for pollen-induced allergic rhinitis. J Allergy Clin Immunol. 2013 Feb;131(2):412-20. doi: 10.1016/j.jaci.2012.10.056.
Results Reference
result
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Pilot Study of Intralymphatic Immunotherapy (ILIT) for House Dust Mite, Cat, and Dog Allergen in Allergic Rhinitis
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