Clinical trial NCT06709092: Study on the Effect and Mechanism of Lupatadine Fumarate in the Treatment of Allergic Rhinitis
Official title: Study on the Effect and Mechanism of Lupatadine Fumarate in the Treatment of Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Allergic Rhinitis
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Rhinoconjunctivitis Quality of Life Questionnaire
timeFrame: baseline and 14 days
measure: Visual analogue scale
timeFrame: baseline and 14 days
measure: The concentration of interleukin 4(IL-4), interleukin 5(IL-5), interleukin 13(IL-13)
timeFrame: baseline and 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
References:
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