ISRCTN11017699已完成未知
Histological, cellular and molecular investigation of steroid responsiveness in chronic obstructive pulmonary disease - the HISTORIC study
niversity Hospital Basel0 个研究点目标入组 190 人开始时间: 2016年11月15日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 190
研究概览
简要总结
2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37385657/ (added 25/07/2023) 2024 Results article in https://doi.org/10.1007/s00408-024-00680-8 (added 22/04/2024) 2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/38812021/ (added 30/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Age =40 years
- •2. COPD, as defined by the GOLD Guidelines and categorization in groups B-D
- •3. No acute exacerbation of COPD or any respiratory infection requiring medical attention or leading to a change in medication within the last 4 weeks
- •4. Unchanged respiratory medication regimen within the last 8 weeks
- •5. At least one exacerbation in the previous year
- •6. Current or ex-smokers with smoking history of = 10 pack-years
- •7. Willingness to participate in a longitudinal, cohort study
- •8. Capability to provide written informed consent
排除标准
- •1. Rapid fatal disease (with life expectancy less than 3 months)
- •2. Pulmonary condition other than COPD as the main respiratory disease
- •3. Current diagnosis of bronchial asthma
- •4. Severe immune-suppression including HIV, organ transplantation, ongoing chemotherapy for cancer
- •5. Pregnancy or breastfeeding
- •6. Chronic use of oral steroids (> 10 mg per day) for COPD
- •7. Intolerance or contraindication to aclidinium, formoterol or budesonide
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