Leukotriene D4 Nasal Provocation Test in Allergic Rhinitis
NCT ID: NCT01963741
Last Updated: 2015-07-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2012-11-30
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
DIAGNOSTIC
SINGLE
Study Groups
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leukotriene D4
Nasal provocation test was induced by leukotriene D4 with a stepwisely concentration method (4 mcg/ml, 8 mcg/ml, 16 mcg/ml).
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.
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).
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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Guangzhou Institute of Respiratory Disease
OTHER
Responsible Party
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Jinping Zheng
Professor,Guangzhou institute of respiratory disease
Principal Investigators
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Jinping Zheng, professor
Role: PRINCIPAL_INVESTIGATOR
Guangzhou Institute of Respiratory Disease
Locations
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Guangzhou institute of respiratory disease
Guangzhou, Guangdong, China
Countries
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References
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Busse WW. The role of leukotrienes in asthma and allergic rhinitis. Clin Exp Allergy. 1996 Aug;26(8):868-79.
Howarth PH, Salagean M, Dokic D. Allergic rhinitis: not purely a histamine-related disease. Allergy. 2000;55 Suppl 64:7-16. doi: 10.1034/j.1398-9995.2000.00802.x.
Patel P, Philip G, Yang W, Call R, Horak F, LaForce C, Gilles L, Garrett GC, Dass SB, Knorr BA, Reiss TF. Randomized, double-blind, placebo-controlled study of montelukast for treating perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2005 Dec;95(6):551-7. doi: 10.1016/S1081-1206(10)61018-6.
Philip G, Williams-Herman D, Patel P, Weinstein SF, Alon A, Gilles L, Tozzi CA, Dass SB, Reiss TF. Efficacy of montelukast for treating perennial allergic rhinitis. Allergy Asthma Proc. 2007 May-Jun;28(3):296-304. doi: 10.2500/aap.2007.28.3000.
Price DB, Swern A, Tozzi CA, Philip G, Polos P. Effect of montelukast on lung function in asthma patients with allergic rhinitis: analysis from the COMPACT trial. Allergy. 2006 Jun;61(6):737-42. doi: 10.1111/j.1398-9995.2006.01007.x.
Pinar E, Eryigit O, Oncel S, Calli C, Yilmaz O, Yuksel H. Efficacy of nasal corticosteroids alone or combined with antihistamines or montelukast in treatment of allergic rhinitis. Auris Nasus Larynx. 2008 Mar;35(1):61-6. doi: 10.1016/j.anl.2007.06.004. Epub 2007 Sep 7.
Nayak A, Langdon RB. Montelukast in the treatment of allergic rhinitis: an evidence-based review. Drugs. 2007;67(6):887-901. doi: 10.2165/00003495-200767060-00005.
Virchow JC, Bachert C. Efficacy and safety of montelukast in adults with asthma and allergic rhinitis. Respir Med. 2006 Nov;100(11):1952-9. doi: 10.1016/j.rmed.2006.02.026. Epub 2006 Apr 12.
Bisgaard H, Olsson P, Bende M. Effect of leukotriene D4 on nasal mucosal blood flow, nasal airway resistance and nasal secretion in humans. Clin Allergy. 1986 Jul;16(4):289-97. doi: 10.1111/j.1365-2222.1986.tb01960.x.
Miadonna A, Tedeschi A, Leggieri E, Lorini M, Folco G, Sala A, Qualizza R, Froldi M, Zanussi C. Behavior and clinical relevance of histamine and leukotrienes C4 and B4 in grass pollen-induced rhinitis. Am Rev Respir Dis. 1987 Aug;136(2):357-62. doi: 10.1164/ajrccm/136.2.357.
Brozek JL, Baena-Cagnani CE, Bonini S, Canonica GW, Rasi G, van Wijk RG, Zuberbier T, Guyatt G, Bousquet J, Schunemann HJ. Methodology for development of the Allergic Rhinitis and its Impact on Asthma guideline 2008 update. Allergy. 2008 Jan;63(1):38-46. doi: 10.1111/j.1398-9995.2007.01560.x.
Riechelmann H, Bachert C, Goldschmidt O, Hauswald B, Klimek L, Schlenter WW, Tasman AJ, Wagenmann M; German Society for Allergology and Clinical Immunology (ENT Section); Working Team for Clinical Immunology. [Application of the nasal provocation test on diseases of the upper airways. Position paper of the German Society for Allergology and Clinical Immunology (ENT Section) in cooperation with the Working Team for Clinical Immunology]. Laryngorhinootologie. 2003 Mar;82(3):183-8. doi: 10.1055/s-2003-38411. No abstract available. German.
Guan W, Zheng J, Gao Y, Jiang C, Xie Y, An J, Yu X, Liu W, Zhong N. Leukotriene D4 and methacholine bronchial provocation tests for identifying leukotriene-responsiveness subtypes. J Allergy Clin Immunol. 2013 Feb;131(2):332-8.e1-4. doi: 10.1016/j.jaci.2012.08.020. Epub 2012 Oct 4.
Guan W, Zheng J, Gao Y, Jiang C, An J, Yu X, Liu W. Leukotriene D4 bronchial provocation test: methodology and diagnostic value. Curr Med Res Opin. 2012 May;28(5):797-803. doi: 10.1185/03007995.2012.678936. Epub 2012 May 3.
Zhu Z, Xie Y, Guan W, Gao YI, Xia S, Liang J, Zheng J. Leukotriene D4 nasal provocation test: Rationale, methodology and diagnostic value. Exp Ther Med. 2016 Jul;12(1):525-529. doi: 10.3892/etm.2016.3324. Epub 2016 May 10.
Other Identifiers
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LTD4NAPT201218
Identifier Type: -
Identifier Source: org_study_id
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