CTRI/2020/08/027322进行中（未招募）3 期
Preventing Adverse Cardiac Events (PACE) in COPD - PACE in COPD
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
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
入选标准
- •1. Have provided written informed consent
- •2. Have COPD defined by 2019 GOLD diagnostic criteria1
- •3. Aged =40 and =85 years
- •4. FEV1 =30% and =70% predicted post-bronchodilator
- •5. FEV1/FVC <0.7 post-bronchodilator
- •6. Have had a COPD exacerbation in the previous 12 months requiring OCS, antibiotics, or both
- •7. If taking maintenance OCS, dosage is stable and =10 mg daily for 4 weeks prior to randomisation
- •8. Resting SBP =100mmHg
- •9. BP and spirometry criteria must be met after the test dose of bisoprolol of 1.25mg
排除标准
- •Participants will be ineligible for the study if any of the following are present:
- •1. Concurrent therapy with any other ß-blocker
- •2. Resting HR <60bpm
- •3. Unstable left HF (i.e. symptomatic and/or necessary change in management in the last 12 weeks, or in clinicians’ opinion)
- •4. Clinically significant pulmonary hypertension, which in the investigator’s opinion would be a contraindication for ß-blocker therapy
- •5. Severe end-stage peripheral vascular disease
- •6. 2nd or 3rd degree heart block
- •7. Currently using or have been prescribed LTOT or resting saturated oxygen level <90% when stable 8. Expected survival is less than 12 months, or in the investigator’s opinion, the person has such unstable disease (of any type) that maintaining 12 months’ participation would be unlikely
- •9. Clinical instability since a MACE in the previous 12 weeks
- •10. Lower respiratory tract infection or AECOPD within the last 8 weeks
- •11. COPD not clinically stable as determined by the investigator
- •12. In the clinician’s view, have asthma-COPD overlap or co-existent asthma are present; or an improvement in FEV1 =400mL post-bronchodilator is observed on two occasions
- •13. Females of child-bearing age and capability who are pregnant or breastfeeding or those in this group not using adequate birth control
- •14. Coexistent illness which precludes participation in the study (poorly controlled diabetes, active malignancy)
- •15. Severe end-stage liver disease defined by INR >1.3 and albumin <30g/L or portal hypertension/ascites
- •16. High chance in the view of the treating physician that the potential participant will not adhere to study requirements
研究者
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