CTIS2022-501035-16-01招募中1 期
COPD - Eosinophil-guided Reduction of Inhaled Corticosteroids (COPERNICOS) - COPERNICOS
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 444
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 至 65+（—）
- 性别
- All
入选标准
- •COPD (verified by a specialist in respiratory medicine + spirometry)., GOLD risk class C/D anytime within the last 2 years (corresponding to 2 = AECOPD and/or =1 AECOPD leading to hospitalization during a 12 months period within the last 2 years) and/or FEV1<30%., Must receive at least during last 4 weeks: LAMA, LABA and ICS., Informed consent.
排除标准
- •Known asthma., Male < 40 years., Female <40 years, if non-menopausal (had menstruation within the last 12 months) conditioned by a negative urine HCG test, Severe mental illness which considerably complicates co-operation., Language problems that considerably complicate co-operation., Current treatment with systemic corticosteroids corresponding to > 5 mg prednisolone per day., Systemic antibiotic treatment (if to participte in microbiota sub-study) or systemic corticosteroid treatment within 14 days (also prophylactic Azithromycin)., Contra-indication to treat with Azithromycin (as listed by the producer)., Non-bacterial exacerbation per investigator judgement in the last 3 months.
研究者
相似试验
进行中（未招募）
1 期
Clinical trial on eosinophil-guided time-updated person-specific reduction of inhaled corticosteroid therapy and prophylactic azithromycin therapy in patients with severe or very severe chronic obstructive pulmonary disease (COPD)Clinicaltrial on eosinophil-guided time-updated person-specific reduction of inhaled corticosteroid therapy and prophylactic azithromycin therapy in patients with severe or very severe chronic obstructive pulmonary disease (COPD)MedDRA version: 21.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855EUCTR2020-003014-12-DKChronic Obstructive Pulmonary Disease Trial Network (COP:TRIN)444
进行中（未招募）
1 期
The effect of reduced corticosteroid therapy in patients with acute exacerbation of COPD1) Whether a reduction of the dose systemic corticosteroids (SC) therapy in patients with acute exacerbation of COPD(AE-COPD) - compared with AE-COPD patients in the standard treatment- leading to non-inferiority 2)Whether there is a difference in treatment response in AE-COPD patients with eosinophilic airway inflammation compared to AE-COPD patients with non-eosinophilic airway inflammation 3) whether a lower accumulated dose SC may be associated with fewer corticosteroid adverse eventsMedDRA version: 20.0 Level: LLT Classification code 10010953 Term: COPD exacerbation System Organ Class: 100000004855EUCTR2015-003441-26-DKChronic Obstructive Pulmonary Disease Trial Network (COP:TRIN)320
已完成
4 期
Eosinophil-guided Reduction of Inhaled CorticosteroidsCOPDInhaled CorticosteroidAzithromycinCOPD ExacerbationPneumoniaNCT04481555Chronic Obstructive Pulmonary Disease Trial Network, Denmark444
进行中（未招募）
1 期
Reversal of steroid insensitivity in COPD by theophyllineChronic Obstructive Pulmonary Disease (COPD)EUCTR2006-003561-13-GBimperial college30
已完成
不适用
Add-on therapy for COPD receiving inhaled bronchodilatorsCOPDJPRN-UMIN000005459EACC (Ehime Asthma COPD Conference)80