Montelukast for Postinfectious Cough

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Montelukast for Postinfectious Cough in Adults

Conditions
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Cough

Intervention / Treatment
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* Drug: Montelukast


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Montelukast<br>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<br>* Patients in experimental treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) .<br>|
| Placebo Comparator: Placebo Comparator<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | 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 |