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Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology and wide-ranging. Cough is usually divided into three categories by time: acute cough, subacute cough and chronic cough. Subacute has a 3~8 weeks course of disease. Its main etiology is postinfectious cough, which is mostly secondary to viral infection.Considering its overexpression in postinfectious patient, Cysteinyl leukotriene (CysLTs) plays a role in gathering eosinophils to respiratory. The level of FENO has a significant correlation with inflammatory airway eosinophils. While CysLTs overexpressed in vivo, the level of FENO may increase. Montelukast, as CysLTs-receptor-1 antagonists， plays a role of controlling airway inflammation and decrease airway high activity by suppressing the biological activity of CysLTs. It is effective in theory to therapy sub-acute cough by Montelukast, to short the course and to relieve cough symptoms as soon as possible. The aim is to research whether FENO can be used as a biomarker to optimized treatment regimen of sub-acute cough.
Patients in electrical treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . Patients in placebo treatment arm were given placebo tablets(main excipient lactose monohydrate,p.o., 10mg, q.d.).All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Montelukast | Experimental | Patients in experimental treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) .All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients. |
|
| Placebo Comparator | Placebo Comparator | Patients in placebo treatment arm were given placebo tablets(main excipient lactose monohydrate,p.o., 10mg, q.d.). All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | Patients in experimental treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| cough visual analogue scale scores post randomisation(area under the curve) | 10 days | |
| Change in Leicester Cough Questionnaire(LCQ) physical,psychological and social domain scores at 10 days post randomisation | 10 days |
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Inclusion Criteria:
Cough is the main or only clinical symptom and was persistent for 3-8 weeks
Chest X-ray reveals no noticeable pathological changes
Not taking angiotensin-converting enzyme inhibitor
Patients must join the programme voluntarily and are able to attend examination and follow-up sessions
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kewu Huang, M.D. | Contact | 86-10-85231167 | kewuhuang@126.com | |
| Min Liu, Master | Contact | 86-0-13522226189 | stream_1980@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Kewu Huang, M.D. | Beijing Chao Yang Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kewu Huang | Recruiting | China | Beijing Municipality | 100190 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15358710 | Background | Morice AH, Fontana GA, Sovijarvi AR, Pistolesi M, Chung KF, Widdicombe J, O'Connell F, Geppetti P, Gronke L, De Jongste J, Belvisi M, Dicpinigaitis P, Fischer A, McGarvey L, Fokkens WJ, Kastelik J; ERS Task Force. The diagnosis and management of chronic cough. Eur Respir J. 2004 Sep;24(3):481-92. doi: 10.1183/09031936.04.00027804. No abstract available. | |
| 16685003 |
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| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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| Kwon NH, Oh MJ, Min TH, Lee BJ, Choi DC. Causes and clinical features of subacute cough. Chest. 2006 May;129(5):1142-7. doi: 10.1378/chest.129.5.1142. |
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| 18614345 | Background | Sato S, Saito J, Sato Y, Ishii T, Xintao W, Tanino Y, Ishida T, Munakata M. Clinical usefulness of fractional exhaled nitric oxide for diagnosing prolonged cough. Respir Med. 2008 Oct;102(10):1452-9. doi: 10.1016/j.rmed.2008.04.018. Epub 2008 Jul 9. |
| 1616444 | Background | Kerr JB. Functional cytology of the human testis. Baillieres Clin Endocrinol Metab. 1992 Apr;6(2):235-50. doi: 10.1016/s0950-351x(05)80149-1. |
| 11865407 | Background | Seymour ML, Gilby N, Bardin PG, Fraenkel DJ, Sanderson G, Penrose JF, Holgate ST, Johnston SL, Sampson AP. Rhinovirus infection increases 5-lipoxygenase and cyclooxygenase-2 in bronchial biopsy specimens from nonatopic subjects. J Infect Dis. 2002 Feb 15;185(4):540-4. doi: 10.1086/338570. Epub 2002 Jan 31. |
| 14533659 | Background | Gentile DA, Fireman P, Skoner DP. Elevations of local leukotriene C4 levels during viral upper respiratory tract infections. Ann Allergy Asthma Immunol. 2003 Sep;91(3):270-4. doi: 10.1016/S1081-1206(10)63529-6. |
| D013568 | Pathological Conditions, Signs and Symptoms |