Coughing Clinical Trial
Official title:
Fractional Concentration of Exhaled NO(FENO) to Direct Montelukast Treatment of Sub-acute Cough:A Prospective, Open Label, Randomized and Placebo-Controlled Trial
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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