Leukotriene D4 Nasal Provocation Test in Allergic Rhinitis

Asthma Clinical Trial

Official title: Leukotriene D4 Nasal Provocation Test: Rationale, Methodology, Diagnostic Value and Its Impact on Airway Inflammation in Allergic Rhinitis With or Without Asthma

Status Completed

Clinical Trial Summary

Leukotrienes play critical roles in the inflammatory process in allergic rhinitis and bronchial asthma, therefore, anti-leukotriene therapy is part of treatment for asthma. However, not all allergic rhinitis accompanied with or without asthma treated with anti-leukotriene were effective. So it is critical to develop a method to identify the response subgroup. In this study, it is assumed that nasal physiological responsiveness to leukotriene nasal provocation test (NPT) is able to gain evidence on the effect of leukotriene on the development of allergic rhinitis and asthma, and is helpful to the use of anti-leukotriene agent. The purpose of the study is to establish the methodology and diagnostic value of leukotriene D4 (LTD4) nasal provocation.

Clinical Trial Description

Nasal provocation test induced by LTD4 will be conducted by measuring nasal airway resistance and airway symptoms in a stepwise concentration of LTD4 by nasal spray. Inflammation biomarkers, such as eosinophilic granulocyte in sputum and nasal lavage, fractional exhaled nitric oxide(FeNO), and lung function before and after nasal provocation will be studied to explore the impact of LTD4 nasal provocation test on airway inflammation. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Rhinitis

• NCT number: NCT01963741
• Study type: Interventional
• Source: Guangzhou Institute of Respiratory Disease
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Completion date: April 2014