Leukotriene D4 Nasal Provocation Test: Rationale, Methodology, Diagnostic Value and Its Impact on Airway Inflammation in Allergic Rhinitis With or Without Asthma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Percentage of participants positive response to leukotriene D4 or histamine nasal provocation test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Diagnostic
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
histamine
Nasal provocation test was induced by histamine with a stepwisely concentration method (0.4 mg/ml, 0.8 mg/ml, 1.6 mg/ml, 3.2mg/ml).
Intervention: leukotriene D4 (Drug)
leukotriene D4
Nasal provocation test was induced by leukotriene D4 with a stepwisely concentration method (4 mcg/ml, 8 mcg/ml, 16 mcg/ml).
Intervention: histamine (Drug)
Outcomes
Primary Outcomes
Percentage of participants positive response to leukotriene D4 or histamine nasal provocation test
Time Frame: Until 1 hour after the nasal provocation test
Nasal airway resistance measured by positive anterior rhinomanometry. Concentration induced 60% increase of nasal airway resistance (PC60-NAR) will be measured and reported; Composite symptoms score defined by reichmann H and his colleagues showed as follows:3-5 sneezes = 1 point (pt), \>5 sneezes = 2 points (pts); rhinorrhoea \< 1 milliliter (mL) = 1 pt, rhinorrhoea \> 1 milliliter = 2 pts; pruritus of the palate or ear or eye= 1 pt, conjunctivitis or cough or urticaria or difficult breathing= 2 pts. Total score ranges from 0 to 6 pts. Positive response to LTD4 nasal provocation test was defined as PC60-NAR less than 16mcg/mL or the symptom score higher than 3.
Secondary Outcomes
- Change from baseline of eosinophils in sputum and nasal lavage and fractional exhaled nitric oxide (FeNO)(4 and 24 hours after the nasal provocation test)
Investigators
Jinping Zheng
Professor,Guangzhou institute of respiratory disease
The First Affiliated Hospital of Guangzhou Medical University