Observation on the Efficacy and Mechanism of SLIT With Dust Mite Allergen for PAR

NCT05570383 | Unknown Phase 2 DMC FDA Drug

• 2 other identifiers: PHAnshungzwkj2023-197
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergic Rhinitis

Keywords

AR (Allergic rhinitis); PAR (perennial allergic rhinitis ); SLIT (Sublingual immunotherapy); ILCs (Innate lymphoid cells); Curative effect; Discussion on mechanism

Outcome Measures

Primary Outcomes (16)

• Change in total nasal symptom score scale

  The total nasal symptom score scale will be collected.

  Baseline, 1 month, 3 months

• Change in Visual analogue scale

  Visual analogue scale will be collected.

  Baseline, 1 month, 3 months

• Change in the quality by life questionnaire of rhinoconjunctivitis

  Quality of life questionnaire of rhinoconjunctivitis will be collected.

  Baseline, 1 month, 3 months

• Change in the Serum levels of IgE

  Serum samples will be collected the levels of IgE

  Baseline, 1 month, 3 months

• Change in the Serum levels of IFN-γ

  Serum samples will be collected the levels of IFN-γ.

  Baseline, 1 month, 3 months

• Change in the Serum levels of IL-4

  Serum samples will be collected the levels of IL-4.

  Baseline, 1 month, 3 months

• Change in the Serum levels of IL-17

  Serum samples will be collected the levels of IL-17.

  Baseline, 1 month, 3 months

• Change in the Serum levels of TNF-α

  Serum samples will be collected the levels of TNF-α.

  Baseline, 1 month, 3 months

• Change in the Serum levels of IL-5

  Serum samples will be collected the levels of IL-5.

  Baseline, 1 month, 3 months

• Change in the Serum levels of IL-9

  Serum samples will be collected the levels of IL-9.

  Baseline, 1 month, 3 months

• Change in the Serum levels of IL-13

  Serum samples will be collected the levels of IL-13.

  Baseline, 1 month, 3 months

• Change in the Serum levels of IL-25

  Serum samples will be collected the levels of IL-25.

  Baseline, 1 month, 3 months

• Change in the Serum levels of IL-33

  Serum samples will be collected the levels of IL-33.

  Baseline, 1 month, 3 months

• Change in the Serum levels of VEGF

  Serum samples will be collected the levels of VEGF.

  Baseline, 1 month, 3 months

• Change in the Serum levels of TSLP

  Serum samples will be collected the levels of TSLP.

  Baseline, 1 month, 3 months

• Change in the Serum levels of IL-22

  Serum samples will be collected the levels of IL-22.

  Baseline, 1 month, 3 months

Secondary Outcomes (1)

• To reveal the correlation between ILCs (ILC1s, ILC2s, ILC3s) and Th1 / Th2 / Th17 cell immunity

  3 months after treatment

Study Arms (2)

In the control group

PLACEBO COMPARATOR

Half of the subjects（30 subjects）will be assigned to the control group，they will be using the Mometasone furoate nasal spray (Nasonex).

Drug: Dust mite drops (trade name: Changdi, Zhejiang Tawu Biotechnology Co. Ltd.).

The experimental group

EXPERIMENTAL

Half of the subjects (30) will be assigned to the experimental group. Received sublingual dust mite drops (trade name: Changdi, Zhejiang Wuwu Biotechnology Co., LTD.) for sublingual immunotherapy.

Drug: Dust mite drops (trade name: Changdi, Zhejiang Tawu Biotechnology Co. Ltd.).

Interventions

Dust mite drops (trade name: Changdi, Zhejiang Tawu Biotechnology Co. Ltd.). DRUG

The experimental group will be with Sublingual immunotherapy (trade name: Changdi, Zhejiang Tawu Biotechnology Co., Ltd.). The control group will be with Mometasone Furoate Aqueous Nasal Spray (NASUNA); The treatment course of the two groups will be 3 months.

Also known as: Brucelated mamisone nasal spray, consisting mainly of an antacid mamisone, measuring 10ml, 50μg x 60 press (0.05%).

In the control group; The experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Those who meet the above diagnostic criteria;
• The course of disease is at least one year;
• Over 18 years old to under 65 years old, both sexes;
• Did not receive specific immunotherapy in the past 1 month or did not use any drugs for AR in the past 1 week;
• Those with normal cognitive function agree to participate in this study and sign the informed consent form.

You may not qualify if:

• Patients with severe nasal septum deviation, chronic rhinosinusitis, bronchial asthma, nasal polyps, upper respiratory tract infection, lung infection and other diseases;
• Patients with severe dysfunction of heart, liver, kidney or autoimmune diseases;
• pregnant or lactating women;
• Allergic constitution and allergic to the experimental drugs and ingredients;
• Patients with drug addiction history;
• Patients with major neuropsychiatric diseases who cannot take medication regularly;
• Patients who are participating in other clinical trials. Patients who met any of the above criteria were excluded.

Sponsors & Collaborators

• People's Hospital of Anshun City of Guizhou Province: lead

Study Sites (1)

Guangjun Tang

Anshan, Guizhou, 561000, China

Location

Related Publications (39)

• 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.

  PMID: 20816182 RESULT

• 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.

  PMID: 21783242 RESULT

• Grossman J. One airway, one disease. Chest. 1997 Feb;111(2 Suppl):11S-16S. doi: 10.1378/chest.111.2_supplement.11s.

  PMID: 9042022 RESULT

• 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.

  PMID: 29771013 RESULT

• 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.

  PMID: 29774680 RESULT

• 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.

  PMID: 15516669 RESULT

• 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.

  PMID: 33273461 RESULT

• 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.

  PMID: 18331513 RESULT

• 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.

  PMID: 25644617 RESULT

• 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.

  PMID: 26141263 RESULT

• 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.

  PMID: 15313870 RESULT

• 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.

  PMID: 29214012 RESULT

• 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.

  PMID: 14674933 RESULT

• 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.

  PMID: 15898976 RESULT

• 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.

  PMID: 15461603 RESULT

• 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.

  PMID: 24679069 RESULT

• 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.

  PMID: 16930249 RESULT

• 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.

  PMID: 21122901 RESULT

• 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.

  PMID: 28602936 RESULT

• 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.

  PMID: 28785597 RESULT

• 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.

  PMID: 30233198 RESULT

• 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.

  PMID: 23791985 RESULT

• 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.

  PMID: 12668793 RESULT

• 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.

  PMID: 26874355 RESULT

• 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.

  PMID: 26932169 RESULT

• 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.

  PMID: 15750716 RESULT

• 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.

  PMID: 19925886 RESULT

• 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.

  PMID: 30263032 RESULT

• 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.

  PMID: 22224763 RESULT

• 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.

  PMID: 30142344 RESULT

• 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.

  PMID: 24631153 RESULT

• 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.

  PMID: 23348417 RESULT

• 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.

  PMID: 19968632 RESULT

• 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.

  PMID: 22627366 RESULT

• 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.

  PMID: 20545698 RESULT

• 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.

  PMID: 28917723 RESULT

• 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.

  PMID: 26922931 RESULT

• 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.

  PMID: 26949057 RESULT

• 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.

  PMID: 25171868 RESULT

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinitis, Allergic, Perennial

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Guangjun Tang, MD

  Principal Investigator

  STUDY CHAIR

• Long Chai, MM

  Head of Otolaryngology

  STUDY DIRECTOR

• Fangming Chen, MB

  Director

  STUDY DIRECTOR

Central Study Contacts

Guangjun Tang, MD

CONTACT

86+13595302195; tgjdoctor@163.com

Long Chai, MM

CONTACT

13985740068; lcassrmyy2022@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Because this test method is not consistent, so this topic will be using single blind method (blind) for the patients, but we will strictly implement spirit blinded phase separation principle, made random don't participate in the experiment, a researcher at the table, will conform to the criteria for the diagnosis of allergic rhinitis patients, according to the medical order, to give corresponding treatment, in the process of experiment, Research implementers do not participate in the statistics of experimental data; The efficacy evaluation index will be evaluated by a third party, blinded to the statistical analysis of the data, and the blind bottom was known only to the study designer and kept by a special person.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHAnshun

Model Details: We will be collected 60 subjects and randomize them into two groups, the trial group and control group. The QC will use a computerized randomization method using EXCEL software to generate random numbers using a RAND function (a total of 60 random numbers). Sixty randomly selected subjects will have a 1 / 2 chance of being randomly assigned to either the experimental or control groups. Patients were randomly assigned to appropriate groups and treatment regimens based on a random number of visits.

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: October 6, 2022
• Study Start: December 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 30, 2024
• Last Updated: October 6, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)