Leukotriene D4 Nasal Provocation Test in Allergic Rhinitis

Guangzhou Institute of Respiratory Disease

Status: Completed

Conditions: Asthma; Allergic Rhinitis

Treatments: Drug: leukotriene D4; Drug: histamine

Study type: Interventional

Funder types: Other

Identifiers

NCT01963741

LTD4NAPT201218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

leukotriene D4

Experimental group

Description:

Nasal provocation test was induced by leukotriene D4 with a stepwisely concentration method (4 mcg/ml, 8 mcg/ml, 16 mcg/ml).

Treatment:

Drug: histamine

histamine

Experimental group

Description:

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).

Treatment:

Drug: leukotriene D4