Allergic Rhinitis Clinical Trial
— ILITOfficial 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
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.
Status | Terminated |
Enrollment | 24 |
Est. completion date | March 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 19 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Gachon University Gil Medical Center | Incheon |
Lead Sponsor | Collaborator |
---|---|
Gachon University Gil Medical Center | Thermo Fisher Scientific |
Korea, Republic of,
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. — View Citation
Kündig 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. — View Citation
Martínez-Gómez JM, Johansen P, Erdmann I, Senti G, Crameri R, Kündig TM. Intralymphatic injections as a new administration route for allergen-specific immunotherapy. Int Arch Allergy Immunol. 2009;150(1):59-65. doi: 10.1159/000210381. Epub 2009 Apr 2. — View Citation
Senti G, Crameri R, Kuster D, Johansen P, Martinez-Gomez JM, Graf N, Steiner M, Hothorn LA, Grönlund H, Tivig C, Zaleska A, Soyer O, van Hage M, Akdis CA, Akdis M, Rose H, Kündig 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. — View Citation
Senti G, Johansen P, Kündig TM. Intralymphatic immunotherapy. Curr Opin Allergy Clin Immunol. 2009 Dec;9(6):537-43. doi: 10.1097/ACI.0b013e3283310ff7. Review. — View Citation
Senti G, Prinz Vavricka BM, Erdmann I, Diaz MI, Markus R, McCormack SJ, Simard JJ, Wüthrich B, Crameri R, Graf N, Johansen P, Kündig 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. — View Citation
von Moos S, Kündig TM, Senti G. Novel administration routes for allergen-specific immunotherapy: a review of intralymphatic and epicutaneous allergen-specific immunotherapy. Immunol Allergy Clin North Am. 2011 May;31(2):391-406, xi. doi: 10.1016/j.iac.2011.02.012. Review. — View 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. — View Citation
Zaleska A, Eiwegger T, Soyer O, van de Veen W, Rhyner C, Soyka MB, Bekpen C, Demiröz D, Treis A, Söllner S, Palomares O, Kwok WW, Rose H, Senti G, Kündig 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rhinoconjunctivitis Quality of Life Questionnaire | up to 12 months after the initial treatment | No | |
Secondary | SNOT-20 | Sino-Nasal Outcome Test | before and 4, 12 months after the initial treatment | No |
Secondary | Skin reactivity | Diameters of wheal provoked by causal allergens in skin prick test and intradermal test | before and 4, 12 months after the initial treatment | No |
Secondary | Serum alllergen-specific IgE level | Serum alllergen-specific IgE level using UNICAP, Thermofisher Scientific, Sweden | before and 4, 12 months after the initial treatment | No |
Secondary | Nasal reactivity | Threshold concentration in nasal provocation test for allergens of Df and Dp | before and 4, 12 months after the initial treatment | No |
Secondary | Cytokines in nasal lavage fluid | Cytokines of Th1, Th2, and Treg in nasal lavage fluid | before and 4, 12 months after the initial treatment | No |
Secondary | Exhaled NO | Exhaled nitric oxide measuring NIOX MINO, Thermofisher Scientific, Sweden | before and 4, 12 months after the initial treatment | No |
Secondary | Allergic rhinitis symptoms during allergen exposure in daily life | Visual analog scare of allergic rhinitis symptoms during allergen exposure in daily life | before and 4, 12 months after the initial treatment | No |
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