Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 1214 for:    HISTAMINE

Leukotriene D4 Nasal Provocation Test in Allergic Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01963741
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : July 9, 2015
Sponsor:
Information provided by (Responsible Party):
Jinping Zheng, The First Affiliated Hospital of Guangzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Asthma Drug: leukotriene D4 Drug: histamine Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
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 Start Date : November 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: leukotriene D4
Nasal provocation test was induced by leukotriene D4 with a stepwisely concentration method (4 mcg/ml, 8 mcg/ml, 16 mcg/ml).
Drug: histamine
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 Name: Guangzhou chemical company (serial number: 1703 )

Experimental: 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).
Drug: leukotriene D4
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 Name: Cayman chemical company (1-800-364-9897 Cat 20310).




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963741


Locations
Layout table for location information
China, Guangdong
Guangzhou institute of respiratory disease
Guangzhou, Guangdong, China, 510120
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Investigators
Layout table for investigator information
Principal Investigator: Jinping Zheng, professor Guangzhou Institute of Respiratory Disease

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Jinping Zheng, Professor,Guangzhou institute of respiratory disease, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT01963741     History of Changes
Other Study ID Numbers: LTD4NAPT201218
First Posted: October 16, 2013    Key Record Dates
Last Update Posted: July 9, 2015
Last Verified: July 2015
Keywords provided by Jinping Zheng, The First Affiliated Hospital of Guangzhou Medical University:
Leukotriene D4
allergic rhinitis
nasal airway resistance
nasal provocation test
nasal hyperreactivity
airway inflammation
asthma
Additional relevant MeSH terms:
Layout table for MeSH terms
Histamine
Histamine phosphate
Histamine Agonists
Histamine Agents
Asthma
Rhinitis
Rhinitis, Allergic
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs