Montelukast for Postinfectious Cough

Cough Clinical Trial

Official title:

Montelukast for Postinfectious Cough in Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02352545
• Other study ID #: Cough
• Status: Recruiting
• Phase: Phase 2
• First received: January 16, 2015
• Last updated: January 28, 2015
• Start date: August 2014
• Est. completion date: October 2015

Study information

• Verified date: January 2015
• Source: Beijing Chao Yang Hospital
• Contact: Kewu Huang, M.D.
• Phone: 86-10-85231167
• Email: kewuhuang[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

• 18 year old, regardless of gender and ethical background

• Not taking angiotensin-converting enzyme inhibitor

• Patients must join the programme voluntarily and are able to attend examination and follow-up sessions

Exclusion Criteria:

• Patients diagnosed with allergic rhinitis, chronic nasosinusitis or bacterial respiratory tract infections

• Patients diagnosed with severe reportorial disease of other severe systemic disease

• Patients who are allergic to any drugs to be tested

• Patients who are non-cooperative during examination sessions or other steps of the trial

• Patients who are not able to or refuse to sign consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cough

Intervention

Drug:
• Montelukast
Patients in experimental treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) .

Locations

Country	Name	City	State
China	Kewu Huang	China	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Chao Yang Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

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. — View Citation

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. — View Citation

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. — View Citation

Kerr JB. Functional cytology of the human testis. Baillieres Clin Endocrinol Metab. 1992 Apr;6(2):235-50. Review. — View Citation

Kwon NH, Oh MJ, Min TH, Lee BJ, Choi DC. Causes and clinical features of subacute cough. Chest. 2006 May;129(5):1142-7. — View Citation

McCool FD. Global physiology and pathophysiology of cough: ACCP evidence-based clinical practice guidelines. Chest. 2006 Jan;129(1 Suppl):48S-53S. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation		10 days	No
Secondary	cough visual analogue scale scores post randomisation(area under the curve)		10 days	No
Secondary	Change in Leicester Cough Questionnaire(LCQ) physical,psychological and social domain scores at 10 days post randomisation		10 days	No