Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06709092

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

Led by Cheng Lei · Updated on 2024-11-29

60

Participants Needed

2

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 to 65 years
  • Diagnosed with allergic rhinitis based on clinical history
  • Positive dust mite sensitization confirmed by skin prick test and/or specific IgE
Not Eligible

You will not qualify if you...

  • Used glucocorticoids, immunomodulatory, antihistamine drugs, or other medications affecting study results within the last month
  • Nasal diseases including upper respiratory infections, chronic sinusitis with or without nasal polyps, and nasal sinus tumors
  • History of nasal sinus surgery
  • Presence of other immune or allergic diseases
  • Severe heart, brain, or lung diseases, aspirin triad, primary ciliary dyskinesia, immune deficiency, or coagulation disorders
  • Pregnant women
  • Smokers

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China, 210000

Not Yet Recruiting

2

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China, 210000

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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