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临床试验/NCT04456205
NCT04456205Unknown不适用

The Clinical Effect of Inhaled Corticosteroid Withdrawal in Chronic Obstructive Pulmonary Disease (COPD) Patients

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Pulmonary Function Test (FEV1)

研究概览

简要总结

According to the WISDOM study, withdraw of inhaled steroids has no effect on the acute exacerbation of chronic obstructive pulmonary disease (COPD), but the lung function of patients with COPD is significantly reclined. In the subgroup analysis of this study, patients with COPD were found to have continued to use inhaled steroids in patients with eosinophilic leukocytes greater than 400 cells/ul or whom has more than two episodes of exacerbation per year. However, in SUNSET study, it was pointed out that withdraw of inhaled steroids had no effect on lung function in patients with COPD, but it was also found that in patients with COPD, eosinophilic leukocytes in the blood were greater than 300 cells/ul, have a better therapeutic response in steroid inhalation. In addition, some studies have shown that in patients with COPD, a decline in lung function after discontinuation of inhaled steroids can make the patient's clinical symptoms worse and increase the risk of acute exacerbations. However, in other comprehensive analytical studies, there are different outcomes. There is no statistically significant difference in the risk of acute exacerbation in patients with COPD after discontinuation of inhaled steroids.

In past studies, it was noted that inhaled steroids cause an increased risk of pneumonia in patients with COPD. However, in these studies, the diagnosis of pneumonia was only from the clinician's suspicion without clear symptom assessment, laboratory examination, microbiological evidence or imaging assessment. Therefore, further research is needed to assess whether patients are suitable for the reduction of inhaled steroids and the impact of COPD in clinical treatment.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
40 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Confirmed patients with COPD (at least one lung function test post bronchodilator FEV1/FVC <70% before the start of the study)
  • Age ≥ 40 years old
  • No acute attack record within half a year
  • Triple therapy (dual long-acting inhaled bronchodilator and inhaled steroid) is stable for more than six months.
  • Eosinophil count in blood <300 cells/ul
  • Clinical symptom assessment CAT score <20

排除标准

  • Suspected or diagnosed with asthma
  • Age <40 years
  • Within half a year, there is a record of moderate to severe acute attacks
  • Eosinophil count in blood ≥300 cells/ul
  • Clinical symptom assessment CAT score ≥20

结局指标

主要结局

Pulmonary Function Test (FEV1)

时间窗: 6 months

Spirometry test with forced expiratory volume in one second (FEV1)

Pulmonary Function Test (FVC)

时间窗: 6 months

Spirometry test with forced vital capacity (FVC)

Frequency of Acute Exacerbation

时间窗: 6 months

Sudden worsening of COPD symptoms with out-patient clinic and emergency department visit or hospitalization

Pulmonary Function Test (FEV1/FVC)

时间窗: 6 months

Spirometry test with FEV1/FVC ratio

次要结局

  • Modified Medical Research Council (mMRC) Dyspnea Scale(6 months)
  • COPD Assessment Test (CAT) score(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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