Leukotriene D4 Nasal Provocation Test in Allergic Rhinitis
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|ClinicalTrials.gov Identifier: NCT01963741|
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : July 9, 2015
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis Asthma||Drug: leukotriene D4 Drug: histamine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|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|
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).
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 )
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).
- 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.
- 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.
- 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).
- 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.
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
|Guangzhou institute of respiratory disease|
|Guangzhou, Guangdong, China, 510120|
|Principal Investigator:||Jinping Zheng, professor||Guangzhou Institute of Respiratory Disease|