Montelukast for Postinfectious Cough
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Experimental: Montelukast 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. |
Drug: Montelukast
Patients in experimental treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) .
|
| 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. |
Outcome Measures
Primary Outcome Measures
- Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation [10 days]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Cough is the main or only clinical symptom and was persistent for 3-8 weeks
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Chest X-ray reveals no noticeable pathological changes
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18 year old, regardless of gender and ethical background
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Not taking angiotensin-converting enzyme inhibitor
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Patients must join the programme voluntarily and are able to attend examination and follow-up sessions
Exclusion Criteria:
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Patients diagnosed with allergic rhinitis, chronic nasosinusitis or bacterial respiratory tract infections
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Patients diagnosed with severe reportorial disease of other severe systemic disease
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Patients who are allergic to any drugs to be tested
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Patients who are non-cooperative during examination sessions or other steps of the trial
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Patients who are not able to or refuse to sign consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Kewu Huang | China | Beijing | China | 100190 |
Sponsors and Collaborators
- Beijing Chao Yang Hospital
Investigators
- Study Director: Kewu Huang, M.D., Beijing Chao Yang Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Cho YS, Park SY, Lee CK, Lee EY, Shin JH, Yoo B, Moon HB. Enhanced cough response to hyperpnea with cold air challenge in chronic cough patients showing increased cough sensitivity to inhaled capsaicin. Allergy. 2003 Jun;58(6):486-91.
- 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.
- Kato A, Schleimer RP. Beyond inflammation: airway epithelial cells are at the interface of innate and adaptive immunity. Curr Opin Immunol. 2007 Dec;19(6):711-20. Epub 2007 Oct 24. Review.
- Kerr JB. Functional cytology of the human testis. Baillieres Clin Endocrinol Metab. 1992 Apr;6(2):235-50. Review.
- Kwon NH, Oh MJ, Min TH, Lee BJ, Choi DC. Causes and clinical features of subacute cough. Chest. 2006 May;129(5):1142-7.
- McCool FD. Global physiology and pathophysiology of cough: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):48S-53S. doi: 10.1378/chest.129.1_suppl.48S. Review.
- Mita H, Turikisawa N, Yamada T, Taniguchi M. Quantification of leukotriene B4 glucuronide in human urine. Prostaglandins Other Lipid Mediat. 2007 Feb;83(1-2):42-9. Epub 2006 Dec 5.
- Montuschi P, Mondino C, Koch P, Barnes PJ, Ciabattoni G. Effects of a leukotriene receptor antagonist on exhaled leukotriene E4 and prostanoids in children with asthma. J Allergy Clin Immunol. 2006 Aug;118(2):347-53. Epub 2006 Jul 3.
- 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. Review.
- Ryan NM, Gibson PG. Extrathoracic airway hyperresponsiveness as a mechanism of post infectious cough: case report. Cough. 2008 Aug 4;4:7. doi: 10.1186/1745-9974-4-7.
- 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.
- 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. Epub 2002 Jan 31.
- Cough