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Leukotriene D4 Nasal Provocation Test in Allergic Rhinitis

Primary Purpose

Allergic Rhinitis, Asthma

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

leukotriene D4

histamine

About this trial

This is an interventional diagnostic trial for Allergic Rhinitis focused on measuring Leukotriene D4, allergic rhinitis, nasal airway resistance, nasal provocation test, nasal hyperreactivity, airway inflammation, asthma

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts 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

Sites / Locations

Guangzhou institute of respiratory disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

leukotriene D4

histamine

Arm Description

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

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).

Outcomes

Primary Outcome Measures

Percentage of participants positive response to leukotriene D4 or histamine 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 Outcome Measures

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

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

Full Information

NCT ID

NCT01963741

First Posted

August 27, 2013

Last Updated

July 8, 2015

Sponsor

Guangzhou Institute of Respiratory Disease

1. Study Identification

Unique Protocol Identification Number

NCT01963741

Brief Title

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

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

February 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guangzhou Institute of Respiratory Disease

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis, Asthma

Keywords

Leukotriene D4, allergic rhinitis, nasal airway resistance, nasal provocation test, nasal hyperreactivity, airway inflammation, asthma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

leukotriene D4

Arm Type

Experimental

Arm Description

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

Arm Title

histamine

Arm Type

Experimental

Arm 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).

Intervention Type

Drug

Intervention Name(s)

leukotriene D4

Other Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

histamine

Other Intervention Name(s)

Guangzhou chemical company (serial number: 1703 )

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of participants positive response to leukotriene D4 or histamine nasal provocation test

Description

Time Frame

Until 1 hour after the nasal provocation test

Secondary Outcome Measure Information:

Title

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

Description

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

Time Frame

4 and 24 hours after the nasal provocation test

Other Pre-specified Outcome Measures:

Title

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

Description

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).

Time Frame

Half an hour after nasal provocation test

Title

Peak Nasal Inspiratory Flow (PNIF)

Description

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.

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jinping Zheng, professor

Organizational Affiliation

Guangzhou Institute of Respiratory Disease

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guangzhou institute of respiratory disease

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510120

Country

China

12. IPD Sharing Statement

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Leukotriene D4 Nasal Provocation Test in Allergic Rhinitis

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