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临床试验/NCT01754220
NCT01754220已完成4 期

The Effects of Alvokast (Montelukast) in Patients With Chronic Cough

Association Asthma, Bulgaria1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

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

发起方
Association Asthma, Bulgaria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Todor Popov

Professor

Association Asthma, Bulgaria

研究点 (1)

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