跳至主要内容
临床试验/TCTR20201111002
TCTR20201111002招募中3 期

Compared add-on Tiotropium handihaler and increasing dose of ICS in moderate and severe adult asthma who controlled with ICS/LABA

Ratchadapiseksompotch Research Fund0 个研究点目标入组 20 人开始时间: 2020年11月11日最近更新:
适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 Years 至 75 Years(—)
性别
All

入选标准

  • 1.Diagnosis of asthma from clinical presentation and/or confirmed at screening with a bronchodilator reversibility (15â€30 minutes after 400 μg salbutamol) resulting in FEV1 or FVC increase of ≥ 12% and ≥ 200 mL or diurnal PEF variability > 10%
  • 2.Diagnosis of asthma lasting 4 weeks or more
  • 3.Patients were required to have been receiving maintenance treatment with stable medium-dose (eg 400 - 800 μg budesonide or equipotent dose) and high-dose ICS (eg > 800 μg budesonide or equipotent dose) and combination with a LABA, for at least 4 weeks prior to screening.
  • 4.Symptomatic asthma was defined as ACT score of 5.Never smoked or be ex-smokers who stopped smoking at least 1 year prior to enrolment, with a smoking history of less than 10 pack-years
  • 6.Reliever usage is only salbutamol.

排除标准

  • 1.Diagnosis COPD by clinical and spirometry
  • 2.Significant unstable concomitant disease e.g. IHD,CKD stage 5,Advanced stage cancer,Bed ridden,Immunocomprommise host[HIV or patients on immunosupressant]
  • 3.On B-blocker or Biologic therapy within 6 momths prior to randomisation.
  • 4.History of acute exacerbation or respiratory tract infection with in 4 weeks prior to randomisation.
  • 5.Reliever usage is combination salbutamol and ipratropium bromide
  • 6.Pregnancy
  • 7.Patients were not permitted to take any investigational drug
  • or patients denied to enroll in the study.

研究者

发起方
Ratchadapiseksompotch Research Fund

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