NCT06709092

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cheng Lei · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

• Allergic Rhinitis

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2024-03-01
• Primary completion: 2024-12-01
• Completion: 2026-12-01
• First posted: 2024-11-29
• Last updated: 2024-11-29

Locations

2 sites across 1 country: China