ISRCTN10497306已完成未知
A randomised, double-blind placebo controlled trial of the effectiveness of the beta-blocker bisoprolol in preventing exacerbations of chronic obstructive pulmonary disease
niversity of Aberdeen0 个研究点目标入组 519 人开始时间: 2018年8月16日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 519
研究概览
简要总结
2024 Results article in https://doi.org/10.1001/jama.2024.8771 (added 20/05/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 21/10/2021:
- •1. Aged =40 years
- •2. A smoking history of =10 pack years ([average number of cigarettes per day x years smoked]/20)
- •3. An established predominant diagnosis of COPD (NICE Guideline definition: post-bronchodilator FEV1<80% predicted, FEV1/FVC<0.7) receiving treatment as per local guidelines. Patients with asthma COPD overlap syndrome (ACOS) will also be eligible.
- •4. A history of =2 exacerbations requiring treatment with antibiotics and/or oral corticosteroid use in the previous year, based on patient report or a history of =2 exacerbations within 12 months of each other requiring treatment with antibiotics and/or oral
- •corticosteroid since March 2019.
- •5. Clinically stable with no COPD exacerbation for at least 4 weeks
- •6. Able to swallow study medication
- •7. Able and willing to give informed consent to participate
- •8. Able and willing to participate in the study procedures and complete the study questionnaire
- •9. Able and willing to undergo spirometric assessment, able to perform an FEV1 manoeuvre as a minimum. During the COVID-19 pandemic, measurement of FEV1 is not required as part of the protocol, and therefore this inclusion criteria does not need to be met.
- •Previous participant inclusion criteria:
- •1. Aged = 40 years
- •2. A smoking history of at least 10 pack years
- •3. An established predominant diagnosis of COPD (NICE Guideline definition: post bronchodilator FEV1<80% predicted, FEV1/FVC<0.7) receiving treatment as per local guidelines’
- •4. A history of at least two exacerbations requiring treatment with antibiotics and/or oral corticosteroid use in the previous year, based on patient report
- •5. Clinically stable with no COPD exacerbation for at least 4 weeks
- •6. Able to swallow study medication
- •7. Able and willing to give informed consent to participate
- •8. Able and willing to participate in the study procedures, complete study questionnaire
- •9. Able and willing to undergo spirometric assessment, able to perform an FEV1 manoeuvre as a minimum
排除标准
- •1. A current sole respiratory diagnosis of asthma
- •2. Any diagnosis of asthma before the age of 40 years
- •3. A predominant respiratory disease other than COPD
- •4. Any significant disease/disorder which, in the investigator’s opinion, either puts the patient at risk because of study participation or may influence the results of the study or the patient's ability to participate in the study
- •5. Previous allocation of a randomisation code in the study or current participation in another interventional study (CTIMP or non-CTIMP)
- •6. Already taking beta-blocker
- •7. Known or suspected hypersensitivity to beta-blocker
- •8. For women, current pregnancy or breastfeeding, or planned pregnancy during the study
- •9. Unable to perform spirometry (FEV1 manoeuvre)
- •10. Current resting (5 minutes sitting) heart rate < 60 bpm
- •11. Current resting (5 minutes sitting) systolic blood pressure < 100 mmHg
- •12. 2nd, 3rd degree heart block (unless pacemaker in situ)
- •13. Conditions for which beta-blocker use is a guideline recommendation, i.e. heart failure, or within the last year: myocardial infarction, acute coronary syndrome
- •14. Current tachyarrythmia or bradyarrhythmia (including sick sinus syndrome, sinoatrial block) requiring treatment
- •15. Current treatment with interacting drugs:
- •15.1. Heart rate limiting drug such as calcium channel blockers (diltiazem, verapamil), ivabradine)
- •15.2. Class-I antiarrhythmic drugs (e.g. quinidine, disopyramide; lidocaine, phenytoin; flecainide, propafenone)
- •15.3. Centrally-acting antihypertensive drugs (e.g. clonidine methyldopa, moxonidine, rilmenidine)
- •16. Severe peripheral arterial occlusive disease, severe forms of Raynaud's syndrome
- •17. Conditions that are known to be triggered by beta-blockers or beta-blocker withdrawal including myasthenia gravis, periodic hypokalaemic paralysis, pheochromocytoma, thyrotoxicosis and psoriasis/history of psoriasis
研究者
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