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Trial record 9 of 30 for:    Dermatophagoides pteronyssinus AND Dermatophagoides farinae

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

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ClinicalTrials.gov Identifier: NCT02269566
Recruitment Status : Terminated (The number of enrolled subjects did not meet the goal during the study)
First Posted : October 21, 2014
Last Update Posted : August 11, 2016
Sponsor:
Collaborator:
Thermo Fisher Scientific
Information provided by (Responsible Party):
Sang Min Lee, Gachon University Gil Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: HollisterStier Drug: Normal saline 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 (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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : August 2014
Actual Primary Completion Date : February 2016
Actual Study Completion Date : March 2016

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 Name: 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 Name: JW-pharma, Seoul, Republic of Korea




Primary Outcome Measures :
  1. Rhinoconjunctivitis Quality of Life Questionnaire [ Time Frame: up to 12 months after the initial treatment ]

Secondary Outcome Measures :
  1. SNOT-20 [ Time Frame: before and 4, 12 months after the initial treatment ]
    Sino-Nasal Outcome Test

  2. 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

  3. 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

  4. 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

  5. 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

  6. Exhaled NO [ Time Frame: before and 4, 12 months after the initial treatment ]
    Exhaled nitric oxide measuring NIOX MINO, Thermofisher Scientific, Sweden

  7. 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



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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, 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

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): NCT02269566


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

Publications:

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Responsible Party: Sang Min Lee, Assistant professor of Division of Pulmonology and Allergy, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT02269566     History of Changes
Other Study ID Numbers: 20140101480
First Posted: October 21, 2014    Key Record Dates
Last Update Posted: August 11, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sang Min Lee, Gachon University Gil Medical Center:
allergic rhinitis
immunotherapy

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