Observation on the Efficacy and Mechanism of SLIT With Dust Mite Allergen for PAR
Summary
Allergic rhinitis is a common and recurrent ear, nose and throat (ENT) disease. It is a chronic or seasonal condition affecting 10% to 20% of the world's population. It is considered one of the most difficult diseases to treat globally and has become a major global health problem. SUblingual immunotherapy (SIT) is currently considered to be an effective pairings therapy that can alter the natural progression of allergic rhinitis through immunomodulatory mechanisms. Immunotherapy is more suitable for patients with moderate to severe intermittent or persistent allergic rhinitis, especially for those with poor drug treatment. This treatment can significantly reduce the severity of allergic rhinitis, reduce the use of allergy medications, and improve the quality of life for many patients. In the development of allergic rhinitis, the regulation of immune balance in Th1 / Th2 / Th17 cells is currently considered to be an important approach in the treatment of allergic rhinitis. But a growing body of evidence suggests that an intrinsic immune response is also the pathogenesis of allergic rhinitis. Innate lymphocytes are involved in mucosal immune formation, lymphocyte development, tissue damage repair and epithelial barrier protection, and play an important role in fighting infection, regulating inflammation and maintaining immune homeostasis. Three subsets of intrinsic lymphocytes (ILC1s, ILC2s, ILC3s) have been proposed to functionally approximate Th1, Th2, and Th17 in helper T lymphocytes (Th), but the results are inconclusive and the mechanism of ILCs role in AR progression is not fully elucidated. Therefore, the purpose of this study was to investigate the efficacy and mechanism of subglossal immunotherapy for perennial allergic rhinitis, and to reveal the correlation between ILCs (ILC1s, ILC2s, ILC3s) and Th1 / Th2 / Th17 cell immunity, and to provide a basis for clinical studies of allergic rhinitis.
Timeline
- Start
- 2022-12-01
- Primary completion
- 2023-12-31
- Completion
- 2024-12-30
Publications
- Results Brozek JL, Bousquet J, Baena-Cagnani CE, Bonini S, Canonica GW, Casale TB, van Wijk RG, Ohta K, Zuberbier T, Schunemann HJ; Global Allergy and Asthma European Network; Grading of Recommendations Assessment, Development and Evaluation Working Group. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revision. J Allergy Clin Immunol. 2010 Sep;126(3):466-76. doi: 10.1016/j.jaci.2010.06.047.
- Results Greiner AN, Hellings PW, Rotiroti G, Scadding GK. Allergic rhinitis. Lancet. 2011 Dec 17;378(9809):2112-22. doi: 10.1016/S0140-6736(11)60130-X. Epub 2011 Jul 23.
- Results Grossman J. One airway, one disease. Chest. 1997 Feb;111(2 Suppl):11S-16S. doi: 10.1378/chest.111.2_supplement.11s.
- Results Ke X, Shen Y, Hu X, Yuan XD, Kang HY, Wang XQ, Hong SL. [Association between IL-27 gene polymorphisms and susceptibility to allergic rhinitis]. Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2016 May 5;30(9):684-688. doi: 10.13201/j.issn.1001-1781.2016.09.004. Chinese.
- Results Zhang YT, Zhang X, Li PZ. [Comparison of PedsQL4.0 and RQLQ scales in the assessment of the quality of life in children with allergic rhinitis]. Lin Chuang Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2017 Jan;31(1):27-29. doi: 10.13201/j.issn.1001-1781.2017.01.008. Chinese.
- Results Bauchau V, Durham SR. Prevalence and rate of diagnosis of allergic rhinitis in Europe. Eur Respir J. 2004 Nov;24(5):758-64. doi: 10.1183/09031936.04.00013904.
- Results Bousquet J, Anto JM, Bachert C, Baiardini I, Bosnic-Anticevich S, Walter Canonica G, Melen E, Palomares O, Scadding GK, Togias A, Toppila-Salmi S. Allergic rhinitis. Nat Rev Dis Primers. 2020 Dec 3;6(1):95. doi: 10.1038/s41572-020-00227-0.
- Results Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Ait-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, Demoly P, Douagui H, Durham SR, van Wijk RG, Kalayci O, Kaliner MA, Kim YY, Kowalski ML, Kuna P, Le LT, Lemiere C, Li J, Lockey RF, Mavale-Manuel S, Meltzer EO, Mohammad Y, Mullol J, Naclerio R, O'Hehir RE, Ohta K, Ouedraogo S, Palkonen S, Papadopoulos N, Passalacqua G, Pawankar R, Popov TA, Rabe KF, Rosado-Pinto J, Scadding GK, Simons FE, Toskala E, Valovirta E, van Cauwenberge P, Wang DY, Wickman M, Yawn BP, Yorgancioglu A, Yusuf OM, Zar H, Annesi-Maesano I, Bateman ED, Ben Kheder A, Boakye DA, Bouchard J, Burney P, Busse WW, Chan-Yeung M, Chavannes NH, Chuchalin A, Dolen WK, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Keith PK, Kemp JP, Klossek JM, Larenas-Linnemann D, Lipworth B, Malo JL, Marshall GD, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Potter P, Price D, Stoloff SW, Vandenplas O, Viegi G, Williams D; World Health Organization; GA(2)LEN; AllerGen. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160. doi: 10.1111/j.1398-9995.2007.01620.x. No abstract available.
- Results Seidman MD, Gurgel RK, Lin SY, Schwartz SR, Baroody FM, Bonner JR, Dawson DE, Dykewicz MS, Hackell JM, Han JK, Ishman SL, Krouse HJ, Malekzadeh S, Mims JW, Omole FS, Reddy WD, Wallace DV, Walsh SA, Warren BE, Wilson MN, Nnacheta LC; Guideline Otolaryngology Development Group. AAO-HNSF. Clinical practice guideline: Allergic rhinitis. Otolaryngol Head Neck Surg. 2015 Feb;152(1 Suppl):S1-43. doi: 10.1177/0194599814561600.
- Results Kenney P, Hilberg O, Laursen AC, Peel RG, Sigsgaard T. Preventive effect of nasal filters on allergic rhinitis: A randomized, double-blind, placebo-controlled crossover park study. J Allergy Clin Immunol. 2015 Dec;136(6):1566-1572.e5. doi: 10.1016/j.jaci.2015.05.015. Epub 2015 Jun 30.
- Results Schwetz S, Olze H, Melchisedech S, Grigorov A, Latza R. Efficacy of pollen blocker cream in the treatment of allergic rhinitis. Arch Otolaryngol Head Neck Surg. 2004 Aug;130(8):979-84. doi: 10.1001/archotol.130.8.979.
- Results Bozek A, Kolodziejczyk K, Kozlowska R, Canonica GW. Evidence of the efficacy and safety of house dust mite subcutaneous immunotherapy in elderly allergic rhinitis patients: a randomized, double-blind placebo-controlled trial. Clin Transl Allergy. 2017 Dec 1;7:43. doi: 10.1186/s13601-017-0180-9. eCollection 2017.
- Results Khinchi MS, Poulsen LK, Carat F, Andre C, Hansen AB, Malling HJ. Clinical efficacy of sublingual and subcutaneous birch pollen allergen-specific immunotherapy: a randomized, placebo-controlled, double-blind, double-dummy study. Allergy. 2004 Jan;59(1):45-53. doi: 10.1046/j.1398-9995.2003.00387.x.
- Results Gidaro GB, Marcucci F, Sensi L, Incorvaia C, Frati F, Ciprandi G. The safety of sublingual-swallow immunotherapy: an analysis of published studies. Clin Exp Allergy. 2005 May;35(5):565-71. doi: 10.1111/j.1365-2222.2005.02240.x.
- Results Marogna M, Spadolini I, Massolo A, Canonica GW, Passalacqua G. Randomized controlled open study of sublingual immunotherapy for respiratory allergy in real-life: clinical efficacy and more. Allergy. 2004 Nov;59(11):1205-10. doi: 10.1111/j.1398-9995.2004.00508.x.
- Results Canonica GW, Cox L, Pawankar R, Baena-Cagnani CE, Blaiss M, Bonini S, Bousquet J, Calderon M, Compalati E, Durham SR, van Wijk RG, Larenas-Linnemann D, Nelson H, Passalacqua G, Pfaar O, Rosario N, Ryan D, Rosenwasser L, Schmid-Grendelmeier P, Senna G, Valovirta E, Van Bever H, Vichyanond P, Wahn U, Yusuf O. Sublingual immunotherapy: World Allergy Organization position paper 2013 update. World Allergy Organ J. 2014 Mar 28;7(1):6. doi: 10.1186/1939-4551-7-6.
- Results Alvarez-Cuesta E, Bousquet J, Canonica GW, Durham SR, Malling HJ, Valovirta E; EAACI, Immunotherapy Task Force. Standards for practical allergen-specific immunotherapy. Allergy. 2006;61 Suppl 82:1-20. doi: 10.1111/j.1398-9995.2006.01219_1.x. No abstract available.
- Results Cox L, Nelson H, Lockey R, Calabria C, Chacko T, Finegold I, Nelson M, Weber R, Bernstein DI, Blessing-Moore J, Khan DA, Lang DM, Nicklas RA, Oppenheimer J, Portnoy JM, Randolph C, Schuller DE, Spector SL, Tilles S, Wallace D. Allergen immunotherapy: a practice parameter third update. J Allergy Clin Immunol. 2011 Jan;127(1 Suppl):S1-55. doi: 10.1016/j.jaci.2010.09.034. Epub 2010 Dec 3. No abstract available.
- Results Brozek JL, Bousquet J, Agache I, Agarwal A, Bachert C, Bosnic-Anticevich S, Brignardello-Petersen R, Canonica GW, Casale T, Chavannes NH, Correia de Sousa J, Cruz AA, Cuello-Garcia CA, Demoly P, Dykewicz M, Etxeandia-Ikobaltzeta I, Florez ID, Fokkens W, Fonseca J, Hellings PW, Klimek L, Kowalski S, Kuna P, Laisaar KT, Larenas-Linnemann DE, Lodrup Carlsen KC, Manning PJ, Meltzer E, Mullol J, Muraro A, O'Hehir R, Ohta K, Panzner P, Papadopoulos N, Park HS, Passalacqua G, Pawankar R, Price D, Riva JJ, Roldan Y, Ryan D, Sadeghirad B, Samolinski B, Schmid-Grendelmeier P, Sheikh A, Togias A, Valero A, Valiulis A, Valovirta E, Ventresca M, Wallace D, Waserman S, Wickman M, Wiercioch W, Yepes-Nunez JJ, Zhang L, Zhang Y, Zidarn M, Zuberbier T, Schunemann HJ. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines-2016 revision. J Allergy Clin Immunol. 2017 Oct;140(4):950-958. doi: 10.1016/j.jaci.2017.03.050. Epub 2017 Jun 8.
- Results Ren M, Tang Q, Chen F, Xing X, Huang Y, Tan X. Mahuang Fuzi Xixin Decoction Attenuates Th1 and Th2 Responses in the Treatment of Ovalbumin-Induced Allergic Inflammation in a Rat Model of Allergic Rhinitis. J Immunol Res. 2017;2017:8254324. doi: 10.1155/2017/8254324. Epub 2017 Jul 13.
- Results Zou XL, Chen ZG, Zhang TT, Feng DY, Li HT, Yang HL. Th17/Treg homeostasis, but not Th1/Th2 homeostasis, is implicated in exacerbation of human bronchial asthma. Ther Clin Risk Manag. 2018 Sep 6;14:1627-1636. doi: 10.2147/TCRM.S172262. eCollection 2018.
- Results Zhang HL, Zheng XY, Zhu J. Th1/Th2/Th17/Treg cytokines in Guillain-Barre syndrome and experimental autoimmune neuritis. Cytokine Growth Factor Rev. 2013 Oct;24(5):443-53. doi: 10.1016/j.cytogfr.2013.05.005. Epub 2013 Jun 21.
- Results Brown V, Warke TJ, Shields MD, Ennis M. T cell cytokine profiles in childhood asthma. Thorax. 2003 Apr;58(4):311-6. doi: 10.1136/thorax.58.4.311.
- Results Hirahara K, Nakayama T. CD4+ T-cell subsets in inflammatory diseases: beyond the Th1/Th2 paradigm. Int Immunol. 2016 Apr;28(4):163-71. doi: 10.1093/intimm/dxw006. Epub 2016 Feb 12.
- Results Jerzynska J, Stelmach W, Rychlik B, Lechanska J, Podlecka D, Stelmach I. The clinical effect of vitamin D supplementation combined with grass-specific sublingual immunotherapy in children with allergic rhinitis. Allergy Asthma Proc. 2016 Mar-Apr;37(2):105-14. doi: 10.2500/aap.2016.37.3921.
- Results Gluck J, Rogala B, Mazur B. Intracellular production of IL-2, IL-4 and IFN-gamma by peripheral blood CD3+ cells in intermittent allergic rhinitis. Inflamm Res. 2005 Feb;54(2):91-5. doi: 10.1007/s00011-004-1328-3.
- Results Ciprandi G, Filaci G, Battaglia F, Fenoglio D. Peripheral Th-17 cells in allergic rhinitis: New evidence. Int Immunopharmacol. 2010 Feb;10(2):226-9. doi: 10.1016/j.intimp.2009.11.004. Epub 2009 Nov 16.
- Results Marshall JS, Warrington R, Watson W, Kim HL. An introduction to immunology and immunopathology. Allergy Asthma Clin Immunol. 2018 Sep 12;14(Suppl 2):49. doi: 10.1186/s13223-018-0278-1. eCollection 2018.
- Results Spits H, Cupedo T. Innate lymphoid cells: emerging insights in development, lineage relationships, and function. Annu Rev Immunol. 2012;30:647-75. doi: 10.1146/annurev-immunol-020711-075053. Epub 2012 Jan 6.
- Results Vivier E, Artis D, Colonna M, Diefenbach A, Di Santo JP, Eberl G, Koyasu S, Locksley RM, McKenzie ANJ, Mebius RE, Powrie F, Spits H. Innate Lymphoid Cells: 10 Years On. Cell. 2018 Aug 23;174(5):1054-1066. doi: 10.1016/j.cell.2018.07.017.
- Results Yagi R, Zhong C, Northrup DL, Yu F, Bouladoux N, Spencer S, Hu G, Barron L, Sharma S, Nakayama T, Belkaid Y, Zhao K, Zhu J. The transcription factor GATA3 is critical for the development of all IL-7Ralpha-expressing innate lymphoid cells. Immunity. 2014 Mar 20;40(3):378-88. doi: 10.1016/j.immuni.2014.01.012. Epub 2014 Mar 13.
- Results Spits H, Artis D, Colonna M, Diefenbach A, Di Santo JP, Eberl G, Koyasu S, Locksley RM, McKenzie AN, Mebius RE, Powrie F, Vivier E. Innate lymphoid cells--a proposal for uniform nomenclature. Nat Rev Immunol. 2013 Feb;13(2):145-9. doi: 10.1038/nri3365.
- Results Xu G, Zhang L, Wang DY, Xu R, Liu Z, Han DM, Wang XD, Zuo KJ, Li HB. Opposing roles of IL-17A and IL-25 in the regulation of TSLP production in human nasal epithelial cells. Allergy. 2010 May;65(5):581-9. doi: 10.1111/j.1398-9995.2009.02252.x. Epub 2009 Nov 25.
- Results Asaka D, Yoshikawa M, Nakayama T, Yoshimura T, Moriyama H, Otori N. Elevated levels of interleukin-33 in the nasal secretions of patients with allergic rhinitis. Int Arch Allergy Immunol. 2012;158 Suppl 1:47-50. doi: 10.1159/000337764. Epub 2012 May 15.
- Results Wang H, Mobini R, Fang Y, Barrenas F, Zhang H, Xiang Z, Benson M. Allergen challenge of peripheral blood mononuclear cells from patients with seasonal allergic rhinitis increases IL-17RB, which regulates basophil apoptosis and degranulation. Clin Exp Allergy. 2010 Aug;40(8):1194-202. doi: 10.1111/j.1365-2222.2010.03542.x. Epub 2010 Jun 7.
- Results Zhong H, Fan XL, Yu QN, Qin ZL, Chen D, Xu R, Chen DH, Lin ZB, Wen W, Fu QL. Increased innate type 2 immune response in house dust mite-allergic patients with allergic rhinitis. Clin Immunol. 2017 Oct;183:293-299. doi: 10.1016/j.clim.2017.09.008. Epub 2017 Sep 13.
- Results Fan D, Wang X, Wang M, Wang Y, Zhang L, Li Y, Fan E, Cao F, Van Crombruggen K, Zhang L. Allergen-Dependent Differences in ILC2s Frequencies in Patients With Allergic Rhinitis. Allergy Asthma Immunol Res. 2016 May;8(3):216-22. doi: 10.4168/aair.2016.8.3.216.
- Results Lombardi V, Beuraud C, Neukirch C, Moussu H, Morizur L, Horiot S, Luce S, Wambre E, Linsley P, Chollet-Martin S, Baron-Bodo V, Aubier M, Moingeon P. Circulating innate lymphoid cells are differentially regulated in allergic and nonallergic subjects. J Allergy Clin Immunol. 2016 Jul;138(1):305-308. doi: 10.1016/j.jaci.2015.12.1325. Epub 2016 Mar 4. No abstract available.
- Results Bartemes KR, Kephart GM, Fox SJ, Kita H. Enhanced innate type 2 immune response in peripheral blood from patients with asthma. J Allergy Clin Immunol. 2014 Sep;134(3):671-678.e4. doi: 10.1016/j.jaci.2014.06.024.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dust mite drops | Vaccine | — | Other |