Study on the Effect and Mechanism of Lupatadine Fumarate in the Treatment of Allergic Rhinitis
Recruiting now · Not applicable
Conditions studied: Allergic Rhinitis
In brief
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.
Key facts
- Study ID
- NCT06709092
- Run by
- Cheng Lei
- People needed
- 60
- Starts
- 2024-03-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2024-11-29
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
- The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China
Full record on ClinicalTrials.gov
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