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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| leukotriene D4 | Experimental | Nasal provocation test was induced by leukotriene D4 with a stepwisely concentration method (4 mcg/ml, 8 mcg/ml, 16 mcg/ml). |
|
| histamine | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Until 1 hour after the nasal provocation test |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 and 24 hours after the nasal provocation test |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of cumulative dosage of methacholine causing a 20% fall in forced expiratory volume in 1 second (PD20FEV1-MCH) | 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). | Half an hour after nasal provocation test |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jinping Zheng, professor | Guangzhou Institute of Respiratory Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangzhou institute of respiratory disease | Guangzhou | Guangdong | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9011329 | Background | Busse WW. The role of leukotrienes in asthma and allergic rhinitis. Clin Exp Allergy. 1996 Aug;26(8):868-79. | |
| 11291780 | Background | 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. |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D017998 | Leukotriene D4 |
| D006632 | Histamine |
| ID | Term |
|---|---|
| D013189 | SRS-A |
| D015289 | Leukotrienes |
| D001095 | Arachidonic Acids |
| D015777 | Eicosanoids |
| D005231 |
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|
|
| 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. |
|
|
| Peak Nasal Inspiratory Flow (PNIF) | 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. | 3 minutes after each concentration of provocation agent administrated into the nostrils |
| 16400895 | Background | 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. |
| 17619558 | Background | 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. |
| 16677244 | Background | 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. |
| 17826020 | Background | 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. |
| 17428106 | Background | 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. |
| 16626955 | Background | 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. |
| 2427255 | Background | 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. |
| 3039881 | Background | 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. |
| 18053015 | Background | 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. |
| 12673517 | Background | 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. |
| 23040886 | Background | 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. |
| 22435894 | Background | 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. |
| 27347089 | Derived | 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. |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D005228 | Fatty Acids, Essential |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
| D015306 | Biogenic Monoamines |
| D001679 | Biogenic Amines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D005021 | Ethylamines |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |