NCT01963741

Leukotriene D4 Nasal Provocation Test in Allergic Rhinitis

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Guangzhou Institute of Respiratory Disease · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Allergic Rhinitis
• Asthma

Interventions

Type	Name	Description
DRUG	leukotriene D4	Nasal challenge using 16% ethanol diluent, the concentration of which corresponded to the highest concentration of LTD4, was undertaken for exclusion of subjects hypersensitive to ethanol or saline. The LTD4 challenge could be initiated provided that NAR increase was \<30%. Ranges of 4 to 16 mcg.mL-1 LTD4 diluents were applied for a double-fold increment approach at intervals of 6 minutes.
DRUG	histamine	Nasal challenge using 0.9% saline, was undertaken for exclusion of subjects hypersensitive to saline. The histamine nasal challenge could be initiated provided that NAR increase was \<30%. Ranges of 0.4 to 3.2 mg.mL-1 histamine diluents were applied for a double-fold increment approach at intervals of 3 minutes.

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-02-01
• Completion: 2014-04-01
• First posted: 2013-10-16
• Last updated: 2015-07-09

Locations

1 site across 1 country: China