Evaluation of Effects of Chronic Dose Exposure to Cardioselective and Non-cardioselective Beta Blockers on Measures of Cardiopulmonary Function in Moderate to Severe COPD.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in airway resistance at 5HZ (R5) using impulse oscillometry from baseline.
研究概览
简要总结
Beta blockers are a type of medication mainly used for heart disease. They are commonly used to treat 'angina' and to prevent heart attacks. Patients with COPD are more likely to suffer from heart disease and so already benefit from this treatment for this reason. In addition to this, new research suggests that there may be further benefit of using beta blockers for COPD, even without also having heart disease.
The reason why beta blockers are not widely used in COPD at present is because of their potential to make symptoms of COPD worse by causing the airways to narrow. Beta blockers are the opposite type of medication to 'beta-agonists' such as salbutamol which you may be taking for symptoms of breathlessness or wheezing. Nevertheless beta blockers are still used in COPD where the benefits (for example heart disease) outweigh any risks.
Current COPD treatment includes inhaled steroids and long acting beta agonists, often given in a combination inhaler (e.g. Seretide or Symbicort) to treat both airway inflammation and airway narrowing, leading to improvement in symptoms. Another drug commonly used is Tiotropium (Spiriva) which is another type of long acting inhaler medication to help with widening the airways.
In this study, we wish to find out if two different types of beta blocker cause different effects on the airways in COPD patients. One type of beta blocker is more 'selective' in acting mainly on the heart, with the other type having more general or 'non-selective' effects on both the heart and lungs. By doing this we will also be able to look at how the beta blockers work alongside the 'usual' inhaler treatment described above.
详细描述
Screening Visit A member of the research team will discuss the Patient Information Sheet with the participant, answer any questions posed and written informed consent will be obtained.
Prior to screen participants will be asked to withhold tiotropium for 48 hours ipratropium bromide for 12 hours and salbutamol for 6 hours.
A general physical examination will be carried out by a qualified medical practitioner.
A pregnancy test from a urine sample will be performed for all female participants with advice issued to both male and female participants to use contraception throughout the duration of the study.
The following will be measured:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe COPD (GOLD stage 2 and 3)
- •FEV1 30-80% predicted
- •No exacerbation in previous 3 months
- •Smoking history ≥ 10 pack years
- •Oxygen saturations≥ 92% on room air at rest
- •ECG demonstrating sinus rhythm
排除标准
- •Use of domiciliary oxygen
- •History of other primary obstructive lung disease including asthma or bronchiectasis
- •History of unstable angina, uncontrolled hypertension or heart failure NYHA class 3-4
- •Overt clinical signs of right heart failure
- •Average resting systolic BP<110mmHg
- •Average resting HR<60bpm
- •Pregnancy or lactation
- •Known or suspected sensitivity to/intolerance of investigational medicinal product
- •Inability to comply with compulsory aspects of protocol
- •Any degree of heart block
- •Concomitant prescription of beta-blockers, rate-limiting calcium channel blockers, digoxin or amiodarone
- •Any clinically significant medical condition that may endanger the health or safety of the participant, or jeopardise the protocol
- •Participation in another trial within the previous 30 days
研究组 & 干预措施
Carvedilol
Beclometasone/Formoterol Beclometasone Tiotropium
干预措施: Carvedilol (Drug)
Carvedilol
Beclometasone/Formoterol Beclometasone Tiotropium
干预措施: Beclometasone/formoterol (Drug)
Carvedilol
Beclometasone/Formoterol Beclometasone Tiotropium
干预措施: Tiotropium (Drug)
Carvedilol
Beclometasone/Formoterol Beclometasone Tiotropium
干预措施: Beclometasone (Drug)
Bisoprolol
Beclometasone/Formoterol Beclometasone Tiotropium
干预措施: Bisoprolol (Drug)
Bisoprolol
Beclometasone/Formoterol Beclometasone Tiotropium
干预措施: Beclometasone/formoterol (Drug)
Bisoprolol
Beclometasone/Formoterol Beclometasone Tiotropium
干预措施: Tiotropium (Drug)
Bisoprolol
Beclometasone/Formoterol Beclometasone Tiotropium
干预措施: Beclometasone (Drug)
结局指标
主要结局
Change in airway resistance at 5HZ (R5) using impulse oscillometry from baseline.
时间窗: 4, 5 and 6 weeks of each treatment period
次要结局
- Change in spirometry measurements from baseline(4, 5 and 6 weeks of each treatment period)
- Change in echocardiogram parameters from baseline(At 6 weeks of each treatment period)
- Change in vital signs from baseline(4, 5, and 6 weeks in each treatment period)
- Change in six minute walk test distance from baseline(4, 5 and 6 weeks of each treatment periods.)
- Change in St George's Respiratory Questionnaire score from baseline(4, 5 and 6 weeks in each treatment arm)
- Change in remaining impulse oscillometry measurements from baseline(4, 5 and 6 weeks of each treatment period)