Evaluating the Outcome of Cardio Selective beta1- Blockers Use in Patients With Chronic Obstructive Pulmonary Disease: A Pilot Study
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- forced vital capacity
研究概览
简要总结
To Evaluate the Outcome of cardio selective beta1 (β1-) blockers use in patients with chronic obstructive pulmonary disease.
Patient education about the COPD and their medications.
详细描述
Chronic obstructive pulmonary disease (COPD) is a common preventable and Treatable airway disorder characterized by symptoms such as dyspnea, chronic Cough, and sputum production along with persistent airflow limitation that is not fully Reversible.
Evidence provided by post hoc analysis of clinical trials and large observational studies suggests a beneficial effect of beta-blockers on mortality and exacerbation in mild to moderate COPD patients.
Evidence concerning cardio selective B blockers. Over the past 20 years' non selective B blockers have largely been replaced with cardio selective blockers. Cardio selective beta blockers such as atenolol and metoprolol are at least 20 times more potent at blocking B-1 receptors than B-2 receptors. At therapeutic doses the B-1 blocking effect, and therefore the risk of bronco constriction, is negligible. In addition there is strong evidence that B-blocked cause up-regulation and sensitization of B-receptors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female.
- •informed consent.
- •Age >40years.
- •FEVl/FVC<70%.
- •diagnosed 3 month before enrollment (mild-moderate)
- •Reversability test pre-post bronchodilators FEVl predicted<200ml/hr and less than 12%.
排除标准
- •Asthmatic patient.
- •patient already use B blockers.
- •Acute exacerbation.
- •Pregnency -lactation.
- •Advanced cardiac, renal or liver disease according to investigator opinion.
研究组 & 干预措施
nebivolol then placebo
Comprises15 copd patients, after recruitment in study and written informed consent, patient's administered nebivolol (1.25 mg for one week then2.5mg fore another one week and 5 mg at 8am for 10 weeks)and washout period4 weeks then shifted to placebo for 12 weeks
干预措施: Nebivolol Tablets (Drug)
placebo then nebivolol
Contain 15 copd patient's after recruitment and Written informed consent administered placebo for 12 weeks and washout period for 4 weeks then shifted to nebivolol for 12 weeks
干预措施: Nebivolol Tablets (Drug)
结局指标
主要结局
forced vital capacity
时间窗: 3 months
amount of air that can be forcibly exhaled from the lung after taking the deepest breath possible (FVC\\liter)
forced expiratory volume in one second
时间窗: 3 month
volume of air exhaled under condition in the first second (FEV1\\liter)
blood pressure
时间窗: 3 month
BP millimetre mercury
次要结局
未报告次要终点
研究者
Asma Shain Suliman
Clinical pharmacist
Ain Shams University