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Trial record 6 of 30 for:    Dermatophagoides pteronyssinus AND Dermatophagoides farinae

Intralymphatic Immunotherapy for House Dust Mite, Dog, and Cat Allergy Using Tyrosine S® in Allergic Rhinitis (ILIT-T)

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ClinicalTrials.gov Identifier: NCT02665754
Recruitment Status : Recruiting
First Posted : January 28, 2016
Last Update Posted : October 17, 2017
Sponsor:
Collaborator:
Korea Research Foundation
Information provided by (Responsible Party):
Sang Min Lee, Gachon University Gil Medical Center

Brief Summary:
The investigators 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 (AR), using allergen extracts for allergen-specific immunotherapy (Tyrosine S, Allergy Therapeutic, West Sussex, UK).

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Biological: ILIT with extract of causal allergen Biological: ILIT with normal saline Drug: Rescue medication for allergic rhinitis Phase 1

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 (Tyrosine S, Allergy Therapeutic, West Sussex, UK) 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 (or mild) local or systemic hypersensitivity reaction. The allergen concentration will not change at second or third dose if there is moderate local or systemic reaction. The allergen concentration will decrease by 10 or 100-fold from previous concentration or further injection will be held 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 (SPT), intradermal test (IDT), blood sampling for serum total immunoglobulin E (IgE), allergen-specific IgE, and allergen-specific immunoglobulin G4 (IgG4), nasal lavage for Th1, Th2, and Treg cytokines, and nasal provocation test (NPT) with Df and/or Dp allergen (in subjects whose AR symptoms are provoked by Df and/or Dp) will be also performed before and 4, 12 months after the initial treatment. In addition, the investigators evaluated the change of subjects' recognition of causal allergens, their avoidance, and AIT during this study. Using VAS, subjects were requested to score the rate of agreement with "Allergen provokes allergic symptoms in daily life", "Allergen avoidance can reduce allergic symptoms", "Allergen-specific Immunotherapy (AIT) can reduce allergic symptoms", "I can pay 50,000 Korean Won (KRW)/month for allergen avoidance", "I can pay 100,000 KRW/month for allergen avoidance", "I can pay 200,000 KRW/month for allergen avoidance", "I can pay 150,000 KRW for each injection of ILIT", "I can pay 300,000 KRW for each injection of ILIT", "I can pay 600,000 KRW for each injection of ILIT" before and after SPT/IDT, after NPT, 4 months and 1 year after ILIT.

Adverse events will be recorded and graded according to Muller classification and Ring and Meissner classification.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy and Adverse Effect of Intralymphatic Immunotherapy With Tyrosine S®, Allergen Extract for Immunotherapy, in Patients With Allergic Rhinitis Induced by House Dust Mite, Dog, and Cat Allergen
Study Start Date : July 2016
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tyrosine

Arm Intervention/treatment
Experimental: Active group
In active group, extract of causal allergen will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval.
Biological: ILIT with extract of causal allergen
0.5 ml of allergen extract from D. farinae, D. pteronyssinus, cat, and/or dog for allergen specific immunotherapy (Tyrosine S, Allergy Therapeutic, UK) will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval.

Drug: Rescue medication for allergic rhinitis
Subjects are requested to administer oral antihistamine (cetirizine) or nasal glucocorticosteroid (ciclesonide) as rescue medication for allergic rhinitis in accordance with severity and frequency of allergic rhinitis symptoms according to Allergic Rhinitis and its Impact on Asthma (ARIA) guideline.

Placebo Comparator: Placebo group
In placebo group, normal saline will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval.
Biological: ILIT with normal saline
0.5 ml of normal saline will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval.

Drug: Rescue medication for allergic rhinitis
Subjects are requested to administer oral antihistamine (cetirizine) or nasal glucocorticosteroid (ciclesonide) as rescue medication for allergic rhinitis in accordance with severity and frequency of allergic rhinitis symptoms according to Allergic Rhinitis and its Impact on Asthma (ARIA) guideline.




Primary Outcome Measures :
  1. RQLQ [ Time Frame: 4 months after the day of first injection of ILIT ]
    Rhinoconjunctivitis Quality of Life Questionnaires


Secondary Outcome Measures :
  1. SNOT-20 [ Time Frame: before and 4, 12 months after the day of first injection of ILIT ]
    Sinonasal Outcome Test-20

  2. Allergic symptoms provoked by causal allergen in daily life [ Time Frame: before and 4, 12 months after the day of first injection of ILIT ]
    Rates scored by subjects using visual analogue scale regarding allergic symptoms provoked by causal allergen in daily life

  3. Rhinitis symptom in nasal provocation test [ Time Frame: before and 4, 12 months after the day of first injection of ILIT ]
    Rhinitis symptom (visual analogue scale: 0~100) during nasal provocation test with allergen of D. farinae and/or D. pteronyssinus in subjects in whom D. farinae and/or D. pteronyssinus is causal allergen.

  4. Skin reactivity in skin prick test [ Time Frame: before and 4, 12 months after the day of first injection of ILIT ]
    Mean diameters of wheal caused by 1- to 10^7- fold dilution of causal allergen in skin prick test and their allergen histamine ratio

  5. Skin reactivity in intradermal test [ Time Frame: before and 4, 12 months after the day of first injection of ILIT ]
    Mean diameters of wheal caused by 10^2- to 10^7- fold dilution of causal allergen in intradermal test and their allergen saline ratio

  6. Serum total IgE level [ Time Frame: before and 4, 12 months after the day of first injection of ILIT ]
    Serum total IgE level using ImmunoCAP (Thermo Fisher Scientific, Uppsala, Sweden)

  7. Allergen-specific IgE for causal allergen [ Time Frame: before and 4, 12 months after the day of first injection of ILIT ]
    Allergen-specific IgE for causal allergen of D. farinae, D. pteronyssinus, cat, and/dog using ImmunoCAP (Thermo Fisher Scientific, Uppsala, Sweden)

  8. Cytokines in nasal lavage fluid before and after nasal provocation test [ Time Frame: before and 4, 12 months after the day of first injection of ILIT ]
    Cytokines of Th1, Th2, and Treg immunity including interleukin-4 (IL-4), IL-5, IL-10, IL-12, IL-13, interferon-gamma (IFN-g), and tumor growth factor-beta (TGF-b) in nasal lavage fluid

  9. Subjects' score (0~100) regarding agreement to "Allergen provokes allergic symptoms in daily life" [ Time Frame: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT ]
    Subjects' score regarding agreement to "Allergen provokes allergic symptoms in daily life" using visual analogue scale (0~100).

  10. Subjects' score (0~100) regarding agreement to "Allergen avoidance can reduce allergic symptoms" [ Time Frame: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT ]
    Subjects' score regarding agreement to "Allergen avoidance can reduce allergic symptoms" using visual analogue scale (0~100).

  11. Subjects' score (0~100) regarding agreement to "Allergen-specific immunotherapy can reduce allergic symptoms" [ Time Frame: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT ]
    Subjects' score regarding agreement to "Allergen-specific immunotherapy can reduce allergic symptoms" using visual analogue scale (0~100).

  12. Willingness to pay for allergen avoidance [ Time Frame: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT ]
    Agreement% scored by subjects using visual analogue scale to "I am willing to pay 50,000, 100,000 or 200,000 Korean Won per month for allergen avoidance"

  13. Willingness to pay for intralymphatic immunotherapy [ Time Frame: before skin prick test / intradermal test, nasal provocation test, and 4, 12 months after the day of first injection of ILIT ]
    Agreement% scored by subjects using visual analogue scale to "I am willing to pay 150,000, 300,000 or 600,000 Korean Won for each injection of intralymphatic immunotherapy"

  14. Nasal mucosal inflammation [ Time Frame: before and 4, 12 months after the day of first injection of ILIT ]
    Inflammatory cell count in nasal mucosal biopsy (/high power field, x400)

  15. RQLQ [ Time Frame: 12 months after the day of first injection of ILIT ]
    Rhinoconjunctivitis Quality of Life Questionnaires

  16. Nasal cavitary volume decrease in nasal provocation test [ Time Frame: before and 4, 12 months after the day of first injection of ILIT ]
    Nasal cavitary volume decrease (basal%) measured by acoustic rhinometry during nasal provocation test with allergen of D. farinae and/or D. pteronyssinus in subjects in whom D. farinae and/or D. pteronyssinus is causal allergen.

  17. Allergen-specific IgG4 for causal allergen [ Time Frame: before and 4, 12 months after the day of first injection of ILIT ]
    Allergen-specific IgG4 for causal allergen of D. farinae, D. pteronyssinus, cat, and/dog using ImmunoCAP (Thermo Fisher Scientific, Uppsala, Sweden)



Information from the National Library of Medicine

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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:

We enrolled subjects who suffered from AR, symptoms of which were provoked by Dp, Df, dog, and/or cat allergen. Concretely, two inclusion criteria should be met.

  1. Sensitization should be verified by skin prick test and the level of serum specific IgE measured by ImmunoCAP® (Thermo Fisher Scientific, Uppsala, Sweden).
  2. Subjects should complain of AR symptoms during exposure of house dust, dog and/or cat in daily life.

Exclusion Criteria:

  1. Uncontrolled or severe asthma according to Global Initiative of Asthma (GINA) guideline including a case in which forced expiratory volume in 1 s (FEV1) was less than 50% of predicted value
  2. Significant cardiovascular, hepatic, renal, hematologic, oncologic, or infectious diseases
  3. Administration of beta blocker, angiotensin converting enzyme inhibitor, tricyclic antidepressant, immunosuppressant including systemic glucocorticosteroid within last 2 weeks
  4. AR caused by other perennial or seasonal allergen
  5. Prior history of allergen-specific immunotherapy
  6. Rejection or low compliance,
  7. Pregnancy or lactation
  8. Vulnerable volunteer

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): NCT02665754


Contacts
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Contact: Sang Min Lee, MD, PhD 82-10-2639-1253 sangminlee77@naver.com
Contact: Sang Pyo Lee, MD, PhD 82-10-3422-7373 allergy21@hotmail.com

Locations
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Korea, Republic of
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 405-760
Contact: Sang Min Lee, M.D., Ph.D.    82-10-2639-1253 ext 82-32-460-8930    sangminlee77@naver.com   
Contact: Sang Pyo Lee, M.D., Ph.D.    82-10-3422-7373 ext 82-32-460-8203    allergy21@hotmail.com   
Sponsors and Collaborators
Gachon University Gil Medical Center
Korea Research Foundation
Investigators
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Principal Investigator: Sang Min Lee, MD, PhD Gachon University Gil Medical Center

Publications of Results:

Other Publications:

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Responsible Party: Sang Min Lee, Assistant Professor, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT02665754     History of Changes
Other Study ID Numbers: GBIRB2016-002
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: October 17, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sang Min Lee, Gachon University Gil Medical Center:
Allergic rhinitis
Injection, intralymphatic
Immunotherapy
Dermatophagoides farinae
Dermatophagoides pteronyssinus
Dogs
Cats

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
Immunologic Factors
Physiological Effects of Drugs