The Effects of Alvokast (Montelukast) in Patients With Chronic Cough
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Difference in the cough reflex parameters (C2 and C5) before and after two weeks of treatment with montelukast
研究概览
简要总结
Montelukast, a leukotriene receptor antagonist, is likely to be effective in the treatment of chronic cough and this could be made objective by measuring cough threshold before and after two weeks of treatment.
详细描述
Chronic cough is typically defined as cough that persists for longer than 8 weeks and is the most common presenting symptom in adults who seek medical treatment in an ambulatory setting. Prospective studies have shown that three conditions account for the etiologic cause of chronic cough in the largest part of immunocompetent, nonsmoking patients with normal chest radiograph findings. In order of frequency, they are upper airway cough syndrome (UACS), previously referred to as postnasal drip syndrome (PNDS), asthma and gastroesophageal reflux disease (GERD). UACS comprises many different conditions including PNDS, acute sinusitis, allergic rhinitis, non-allergic rhinitis (postinfectious rhinitis, rhinitis medicamentosa, vasomotor rhinitis, rhinitis due to physical or chemical irritants). Cough occurs in all asthmatics, and in a subset of patients with cough-variant asthma (CVA), it is the only presenting symptom. In these cases it is well controlled with inhaled corticosteroids and beta-2 agonists. GERD is another cause that should be contemplated when anti-tussive or anti-inflammatory/anti-allergic treatment do not render results and when there are presenting symptoms suggestive of it. Moreover, factors like smoking and use of ACE-inhibitors should also be taken into account.
Leukotrienes are very important agents in the inflammatory response. It is known that they are contributing significantly to the pathological processes in asthma. Montelukast is a leukotriene receptor antagonist which blocks the bonding of leukotrienes to their receptors thus inhibiting their inflammatory, bronchoconstrictive and mucosecretory effects. Multiple clinical trials have demonstrated the ability of the leukotriene antagonists to improve symptoms, pulmonary function and bronchial hyperresponsiveness in patients with asthma. However, not much is known about their effects in people with chronic cough. Studies have been carried out in an attempt to find out the effects of montelukast in some forms of chronic cough. Nevertheless, the impact of montelukast on objective parameters such as cough reflex threshold, has not been explored. The investigators also reckon that montelukast will affect exhaled breath temperature - a novel surrogate marker of airway inflammation recognized lately
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 60 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic cough: cough persisting for more than 8 consecutive weeks
排除标准
- •Current use of ACE-inhibitors
- •Use of systemic steroids in the last 4 weeks
- •Pregnancy
- •Concomitant severe disease
研究组 & 干预措施
Montelukast
Montelukast tablets: adults - 10 mg, children - 5mg taken daily for two weeks
干预措施: Montelukast (Drug)
结局指标
主要结局
Difference in the cough reflex parameters (C2 and C5) before and after two weeks of treatment with montelukast
时间窗: 7 months
Difference in average scores on modified Leicester Cough Questionnaire (LCQ) before and after two weeks of treatment with montelukast
时间窗: 7 months
次要结局
- Difference in pulmonary function parameters (FVC, FEV1, PEF), before and after two weeks of treatment with montelukast(7 months)
- Difference in Exhaled breath temperature (EBT) before and after two weeks of treatment with montelukast(7 months)
- Difference in laboratory markers (CBC, CRP, total IgE, ESP, MPO) before and after two weeks of treatment with montelukast(7 months)
研究者
Prof. Todor Popov
Professor
Association Asthma, Bulgaria
