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NCT Number: NCT01963741

Leukotriene D4 Nasal Provocation Test in Allergic Rhinitis

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.

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Key information

Conditions

Allergic Rhinitis Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

leukotriene D4

Drug

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.

Other names: Cayman chemical company (1-800-364-9897 Cat 20310).

Histamine

Drug

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.

Other names: Guangzhou chemical company (serial number: 1703 )

Primary outcomes

  1. 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

  1. Change from baseline of eosinophils in sputum and nasal lavage and fractional exhaled nitric oxide (FeNO)

    Time frame: 4 and 24 hours after the nasal provocation test

    Biomarkers in upper and lower airways such as eosinophils in sputum and nasal lavage and fractional exhaled nitric oxide (FeNO) will be studied.

Other outcomes

  1. Change from baseline of cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PD20FEV1-MCH)

    Time frame: Half an hour after nasal provocation test

    The increase of brochial hyperresponsiveness induced by nasal provocation test was assessed by the decrease of cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PD20FEV1-MCH).

  2. Peak Nasal Inspiratory Flow (PNIF)

    Time frame: 3 minutes after each concentration of provocation agent administrated into the nostrils

    The peak nasal inspiratory flow (PNIF) is measured by PNIF meter (in-check dial, Clement Clarke International Ltd.); Change from baseline of peak nasal inspiratory flow (PNIF) at the end of nasal provocation test will be reported.

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 16, 2013
Registry last updated
Jul 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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