NCT06709092 Study on the Effect and Mechanism of Lupatadine Fumarate in the Treatment of Allergic Rhinitis
| NCT ID | NCT06709092 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cheng Lei |
| Condition | Allergic Rhinitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-03-01 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT06709092 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Allergic Rhinitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06709092 currently recruiting?
Yes, NCT06709092 is actively recruiting participants. Visit ClinicalTrials.gov or contact Cheng Lei to inquire about joining.
Where is the NCT06709092 trial being conducted?
This trial is being conducted at Nanjing, China, Nanjing, China.
Who is sponsoring the NCT06709092 clinical trial?
NCT06709092 is sponsored by Cheng Lei. The trial plans to enroll 60 participants.