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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Rhinoconjunctivitis Quality of Life Questionnaire — baseline and 14 days
  To measure the functional impairments that are most troublesome to adult patients as a result of their rhinoconjunctivitis. Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure. 7-point scale (0 = not impaired at all - 6 = severely impaired). Higher scores reflect lower quality of life.
• Visual analogue scale — baseline and 14 days
  Results VAS are well validated for the measurement of AR symptoms and correlate well with the ARIA (allergic rhinitis and its impact on asthma) severity classification. Patients were scored by questionnaire before and after treatment, and the change in score before and after treatment was the primary outcome measure. Range: 0-10. Higher scores reflect more pain and severity.
• The concentration of interleukin 4(IL-4), interleukin 5(IL-5), interleukin 13(IL-13) — baseline and 14 days
  It reflects Th2 immune response in patients with allergic rhinitis

Trial sites (2)

More Cheng Lei trials in China

Other trials for the same condition