Clinical trial NCT01963741: Leukotriene D4 Nasal Provocation Test in Allergic Rhinitis
Official title: Leukotriene D4 Nasal Provocation Test: Rationale, Methodology, Diagnostic Value and Its Impact on Airway Inflammation in Allergic Rhinitis With or Without Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis
Asthma
Keywords: Leukotriene D4
allergic rhinitis
nasal airway resistance
nasal provocation test
nasal hyperreactivity
airway inflammation
asthma
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2013-10-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients with allergic rhinitis accompanied with or without asthma
* positive skin prick test (SPT)
* had no acute upper or lower airway infection 2 weeks prior to study
* no oral or nasal anti-histamines
* no leukotriene receptor antagonists for 1 week
* no oral or nasal and inhaled corticosteroids for 2 weeks

Exclusion Criteria:

* smokers
* a past confirmed history of chronic respiratory disease other than asthma
* other severe systemic diseases (myocardial infarction, malignant tumor, etc.)
* under immunotherapy
* unable to complete the test or had limited understanding
* pregnancy

Primary outcomes:
measure: Percentage of participants positive response to leukotriene D4 or histamine nasal provocation test
timeFrame: Until 1 hour after the nasal provocation test
Secondary outcomes:
measure: Change from baseline of eosinophils in sputum and nasal lavage and fractional exhaled nitric oxide (FeNO)
timeFrame: 4 and 24 hours after the nasal provocation test
Other outcomes:
measure: Change from baseline of cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PD20FEV1-MCH)
timeFrame: Half an hour after nasal provocation test
measure: Peak Nasal Inspiratory Flow (PNIF)
timeFrame: 3 minutes after each concentration of provocation agent administrated into the nostrils
Locations:
city: Guangzhou
country: China
facility: Guangzhou institute of respiratory disease
state: Guangdong
Study officials:
affiliation: Guangzhou Institute of Respiratory Disease
name: Jinping Zheng, professor
role: PRINCIPAL_INVESTIGATOR
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