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Study on the Effect and Mechanism of Lupatadine Fumarate in the Treatment of Allergic Rhinitis

NCT ID: NCT06709092

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2026-12-31

Brief Summary

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In China, the prevalence of allergic rhinitis reaches 17.6% and is increasing year by year, seriously affecting the quality of life of patients. Some patients still cannot be effectively treated. So it is urgent to study the pathogenesis of AR and find new therapeutic targets. Lupatadine fumarate has the dual effects of antihistamine and platelet-activating factor (PAF), and it is the only potent and highly effective allergy drug with both antihistamine and PAF antagonism currently on the marke. The exact mechanism of Lupatadine fumarate in relieving nasal congestion in patients with AR is unknown. Tight junction proteins (TJs) play an important role in maintaining endothelial barrier function, and TJ disruption disrupts barrier function and promotes inflammation. 15-LOX(15-lipoxygenase) disrupts tight junctions at the blood-brain barrier. It increases cerebral vascular permeability and contributes to cerebral edema. In a mouse model of atherosclerosis, 15(S)-HETE, the major metabolite of 15-LOX, enhances the phosphorylation of ZO-2 at the Thr-1/1 residue through MEK1-ERK770/772 activation, leading to the dissociation of ZO-1 from occludin and disrupting the endothelial TJ and its barrier function. So we want to study the effects and mechanisms of lupatadine fumarate in the treatment of allergic rhinitis (AR) and whether lupatadine fumarate is directly related to 15-LO1.

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Allergic rhinitis

For patients with AR, patients were given lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals) 1 tablet once daily at bedtime for 14 days.

Group Type EXPERIMENTAL

lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals)

Intervention Type DRUG

For patients with AR, patients were given lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals) 1 tablet once daily at bedtime for 14 days.

Interventions

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lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals)

For patients with AR, patients were given lupatadine fumarate (Luso®, Yangzijiang Pharmaceuticals) 1 tablet once daily at bedtime for 14 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients (18-65 years).
* Patients with allergic rhinitis were diagnosed based on clinical history and positive dust mite sensitization tests (skin prick test and/or specific IgE).

Exclusion Criteria

* Received glucocorticoids, immunomodulatory, antihistamine drugs, and other medications that may affect the study results within the last 1 month.
* Nasal diseases such as upper respiratory tract infections, chronic sinusitis with or without nasal polyps, and nasal sinus tumors.
* History of nasal sinus surgery.
* With other immune and allergic diseases.
* Patients with a combination of severe cardiac, cerebrovascular or pulmonary - diseases, aspirin triad, primary ciliary dyskinesia, immune deficiency, and coagulation disorders.
* Pregnant women.
* Smokers.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cheng Lei

OTHER

Sponsor Role lead

Responsible Party

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Cheng Lei

chief physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status NOT_YET_RECRUITING

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Lei Cheng, Doctor

Role: primary

[email protected]
0086-13776620807

Cheng Lei, Chief physician

Role: primary

[email protected]
0086-13776620807

References

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Al-Digheari A, Mahboub B, Tarraf H, Yucel T, Annesi-Maesano I, Doble A, Lahlou A, Tariq L, Aziz F, El Hasnaoui A. The clinical burden of allergic rhinitis in five Middle Eastern countries: results of the SNAPSHOT program. Allergy Asthma Clin Immunol. 2018 Nov 19;14:63. doi: 10.1186/s13223-018-0298-x. eCollection 2018.

Reference Type BACKGROUND
PMID: 30473712 (View on PubMed)

Eifan AO, Durham SR. Pathogenesis of rhinitis. Clin Exp Allergy. 2016 Sep;46(9):1139-51. doi: 10.1111/cea.12780.

Reference Type BACKGROUND
PMID: 27434218 (View on PubMed)

Cheng L, Chen J, Fu Q, He S, Li H, Liu Z, Tan G, Tao Z, Wang D, Wen W, Xu R, Xu Y, Yang Q, Zhang C, Zhang G, Zhang R, Zhang Y, Zhou B, Zhu D, Chen L, Cui X, Deng Y, Guo Z, Huang Z, Huang Z, Li H, Li J, Li W, Li Y, Xi L, Lou H, Lu M, Ouyang Y, Shi W, Tao X, Tian H, Wang C, Wang M, Wang N, Wang X, Xie H, Yu S, Zhao R, Zheng M, Zhou H, Zhu L, Zhang L. Chinese Society of Allergy Guidelines for Diagnosis and Treatment of Allergic Rhinitis. Allergy Asthma Immunol Res. 2018 Jul;10(4):300-353. doi: 10.4168/aair.2018.10.4.300.

Reference Type BACKGROUND
PMID: 29949830 (View on PubMed)

Ren Q, Ren L, Ren C, Liu X, Dong C, Zhang X. Platelet endothelial cell adhesion molecule-1 (PECAM1) plays a critical role in the maintenance of human vascular endothelial barrier function. Cell Biochem Funct. 2015 Dec;33(8):560-5. doi: 10.1002/cbf.3155. Epub 2015 Nov 25.

Reference Type BACKGROUND
PMID: 26607202 (View on PubMed)

Soon AS, Chua JW, Becker DL. Connexins in endothelial barrier function - novel therapeutic targets countering vascular hyperpermeability. Thromb Haemost. 2016 Oct 28;116(5):852-867. doi: 10.1160/TH16-03-0210. Epub 2016 Aug 4.

Reference Type BACKGROUND
PMID: 27488046 (View on PubMed)

Cong X, Kong W. Endothelial tight junctions and their regulatory signaling pathways in vascular homeostasis and disease. Cell Signal. 2020 Feb;66:109485. doi: 10.1016/j.cellsig.2019.109485. Epub 2019 Nov 23.

Reference Type BACKGROUND
PMID: 31770579 (View on PubMed)

Other Identifiers

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2023-SR-674

Identifier Type: -

Identifier Source: org_study_id