跳至主要内容
临床试验/NCT02934945
NCT02934945Unknown4 期

Treatment Efficacy of Budesonide/Formoterol in Cough Variant Asthma and Typical Asthma Patients

Zhujiang Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
30
试验地点
1
主要终点
Forced Expiratory Volume in first second

研究概览

简要总结

Bronchial asthma is a common respiratory disease characterized by chronic airway inflammation, which have been affecting about 1-18% of the population in the world, causing tremendous economic burden for the patients and countries. Generally, asthma is a heterogeneous disease, and it could be classified into many types on the basis of symptoms, that is, typical asthma, cough variant asthma, and chest tightness variant asthma etc. Typical asthma (TA) is defined according to the history of repeated respiratory symptoms such as wheeze, shortness of breath, chest tightness, and cough, usually with reversible airflow limitation, airway hyper-responsiveness, and airway remodeling. Cough variant asthma (CVA) is characterized by the single manifestation, recurrent cough, which could be improved after the use of bronchodilators. However, according to different guidelines, it is still controversial on the treatment of CVA and TA. The guidelines of Global Initiative for Asthma(GINA) in 2014 put forward the treatment of TA patients, but did not list the treatment specific to CVA. The guideline of ACCP(American College of Chest Physicians) and cough guidelines of China are proposed to treat the CVA effectively with bronchial diastolic drug. Inhaled corticosteroids (ICS) and leukotriene receptor antagonists are effective for the treatment of CVA. Currently, more and more studies supported that application of ICS combined with bronchial dilation agents is more beneficial to CVA patients. Budesonide/formoterol is a compound of ICS and long-acting beta2-agonist(LABA), which can not only be used as a maintenance medication, but also be used as a relief medication, namely, budesonide/formoterol treatment regimen for SMART (Symbicort as both maintenance and reliever therapy). Most studies show that SMART treatment can be used in the treatment of TA patients. But the study on whether budesonide/formoterol can be used to treat CVA is still little. To provide basis for clinical medication guidance for patients with CVA and TA, this study will enroll 30 patients with TA or CVA , who will be required to adopt the SMART regimen in the following 6 months.The symptom score, airway inflammation, pulmonary function and airway reactivity changes, will be measured every mouth. After the study finished, the investigators will compare the difference between the two groups.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
15 Years 至 75 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • first diagnosed corresponding to the diagnostic standards established by Asthma Committee, Respiratory Society, Chinese Medical Association, or previously diagnosed asthma without regular treatment
  • Mch bronchial provocation test is positive
  • the chest X-ray is normal.

排除标准

  • accompanied by other disease of respiratory system
  • combined with serious illness of other system, such as myocardial infarction, severe arrhythmia, malignant tumors and so on
  • women with pregnancy or lactation.

研究组 & 干预措施

patients with CVA(CVA group)

Other

budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for six months

干预措施: budesonide 160μg/formoterol 4.5μg (Drug)

patients with TA(TA group)

Other

budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for six months

干预措施: budesonide 160μg/formoterol 4.5μg (Drug)

结局指标

主要结局

Forced Expiratory Volume in first second

时间窗: up to six months

次要结局

  • Asthma Controlled Test(up to six months)
  • forced vital capacity(up to six months)
  • Bronchial Provocation Test(up to six months)
  • Fractional Exhaled Nitric Oxide(up to six months)

研究者

发起方
Zhujiang Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验