Montelukast for Postinfectious Cough in Adults
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental: Montelukast
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.
干预措施: Montelukast (Drug)
结局指标
主要结局
Change in Leicester Cough Questionnaire(LCQ) total and domain scores at 10 days post randomisation
时间窗: 10 days
次要结局
- 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)
研究者
Liu Min
Beijing Chao Yang Hospital
Beijing Chao Yang Hospital