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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.


Clinical Trial Description

This project is a prospective, open label, randomized and controlled trial. All subacute cough patients that met the inclusion/exclusion criteria were recruited after signing the consent form. Patients were randomized into biomarker treatment arm and standard treatment arm. Positive or negative biomarker expression was confirmed by assessing fractional concentration of exhaled NO (FENO) level, FENO<25ppb was regarded as negative and FENO≥25ppb was regarded as positive.

Patients in biomarker guided positive treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . Patients in biomarker guided negative treatment arm were given placebo tablets(p.o., 10mg, q.d.). Patients in standard 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.

Examine results of all patients from all arms were recorded before and after the 10 day treatment. The examine recorded are FENO levels, cough symptom assessment, cough visual assessment, Leicester cough questionnaire, total white blood cell count, neutrophil blood percentage, eosinophil blood percentage. Patient cough free days after treatment and Montelukast Sodium Tablets . Follow up was carried out at the 8th week after first record of symptom and 2 month after treatment. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02303600
Study type Interventional
Source Beijing Chao Yang Hospital
Contact Kewu Huang, M.D.
Phone 86-10-85231167
Email kewuhuang@126.com
Status Recruiting
Phase N/A
Start date August 2014
Completion date August 2015

See also
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Completed NCT01774292 - Effect of Intracuff Alkalinized Lidocaine on Coughing Incidence at Extubation Phase 4
Completed NCT01518439 - Instrumental and Manual Increase of Couch in Neuromuscular Patients N/A
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Suspended NCT02655562 - Fractional Concentration of Exhaled NO(FeNO) to Direct The Treatment of Sub-acute Cough Phase 4