ACTRN12621001503819尚未招募4 期
The LABA/LAMA and beta-blocker regimen in COPD: the effect of combination umeclidinium/vilanterol (Anoro®/Ellipta®) therapy on FEV1, exercise tolerance, and broncho-protection in COPD.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 40 Years 至 o limit（—）
- 性别
- All
入选标准
- •Physician diagnosis of COPD
- •Post-bronchodilator FEV1/FVC <0.70
- •Post-bronchodilator FEV1 between 30% and 80% of predicted
- •Minimum 10 pack-year smoking history
- •Age 40 years and over
- •BP and spirometry criteria must be met after test dose of carvedilol
- •Written informed consent
排除标准
- •Self-reported diagnosis of asthma
- •Post-bronchodilator improvement in FEV1 >400ml
- •Lower respiratory tract infection within the previous 8 weeks
- •COPD not clinically stable/COPD exacerbation within previous 8 weeks
- •Requiring home oxygen/resting O2 saturations <90% on air when stable
- •Currently in the acute phase of a pulmonary rehabilitation program
- •Previously recorded allergy or intolerance of beta-blockers or any anticholinergic/muscarinic receptor antagonist, symp, lactose/milk protein or magnesium stearate
- •Frequent episodes of hypoglycaemia (in patients with Diabetes Mellitus)
- •Pregnancy & breastfeeding
- •Concurrent use of other rate-limiting medication (e.g. rate-limiting calcium channel blockers)
- •Already taking beta-blocker treatment
- •Uncontrolled Heart Failure
- •Systolic Blood Pressure less or equal to 110mmHg or >180mmHg at time of screening
- •Diastolic blood pressure >100mmHg
- •Bradycardia defined as <60bpm at time of screening
- •Persistent tachyarrhythmia, including atrial fibrillation rate >120bpm
- •Pre-existing 2nd/3rd degree AV-block
- •Clinical instability or major cardiac event in the previous 12 weeks
- •Severe Peripheral Vascular Disease
- •Severe or unstable liver disease
- •Acute angle closure glaucoma
- •Any other condition, at the discretion of the investigator, which may impact on the safety of participants or feasibility of study results
研究者
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