2022-501035-16-01招募中4 期
COPD - Eosinophil-guided Reduction of Inhaled Corticosteroids (COPERNICOS)
Gentofte Hospital, Frederiksberg Hospital10 个研究点 分布在 1 个国家目标入组 444 人开始时间: 2022年8月23日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 444
- 试验地点
- 10
- 主要终点
- Number of hospitalization-requiring exacerbations and/or death within 365 days.
研究概览
简要总结
ICS: In COPD patients with GOLD class E and/or FEV1 < 30%, an eosinophil-guided administration of ICS treatment regimen is associated with no apparent loss of efficiency. Azithromycin: In COPD patients with GOLD class E and/or FEV1 < 30%, the use of low dose Azithromycin can result in a reduction in admissions with COPD exacerbation or death from all causes within 365 days as compared to placebo.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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.
研究组 & 干预措施
-
Experimental
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Number of hospitalization-requiring exacerbations and/or death within 365 days.
Number of hospitalization-requiring exacerbations and/or death within 365 days.
次要结局
- Death or “uncontrolled AECOPD tendency” within 365 days.
- Number of moderate/severe exacerbation within 365 days.
- Cumulative dose of inhaled corticosteroids within 365 days.
- Cumulative dose of systemic corticosteroids within 365 days.
- Change in lung function (ΔFEV1) from baseline to 365 days.
- Change in blood eosinophils from baseline to 365 days (eosinophilic trajectories).
- New diagnosis of diabetes mellitus within 365 days.
- Change in HbA1c from baseline to 365 days.
- Antibiotic-requiring infections within 365 days.
- Difference in respiratory microbiota abundance and diversity at 12 months between treatment arms.
- Change in COPD-related quality of life (Based on COPD Assessment Test - CAT) from baseline to 365 days.
- Number who progress to MRC -dyspnea score from < 3 to ≥3 anytime during follow-up (assessed every 3 months).
- Number of admission requiring NIV treatment or admissions to intensive care within 365 days.
- Mortality within 365 days.
- Difference in immunological profile including cytokines and chemokines in the upper airways from baseline to 12 months between treatment arms
- “Days alive and out of hospital" within 365 days after recruitment
研究者
Pradeesh Sivapalan
Scientific
Gentofte Hospital
研究点 (10)
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