Clinical Trial: Montelukast for Postinfectious Cough
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Montelukast for Postinfectious Cough in Adults
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.
Detailed Summary: 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.
Sponsor: Beijing Chao Yang Hospital
Current Primary Outcome: Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation [ Time Frame: 10 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- cough visual analogue scale scores post randomisation(area under the curve) [ Time Frame: 10 days ]
- Change in Leicester Cough Questionnaire(LCQ) physical,psychological and social domain scores at 10 days post randomisation [ Time Frame: 10 days ]
Original Secondary Outcome: Same as current
Information By: Beijing Chao Yang Hospital
Dates:
Date Received: January 16, 2015
Date Started: August 2014
Date Completion: October 2015
Last Updated: January 28, 2015
Last Verified: January 2015
