Evaluation of effects of chronic dose exposure to cardioselective and non-cardioselective beta blockers on measures of cardiopulmonary function in moderate to severe COPD. - Beta Blocker therapy in moderate to severe COPD. ANDA2

Tayside Clinical Trials Unit, University of Dundee0 个研究点目标入组 45 人开始时间: 2012年7月27日最近更新: 2019年6月30日

试验速览

暂无简介。

•Male and female volunteers aged 40-80 years with stable moderate to severe COPD (GOLD stage 2&3).
•FEV1 30-80% predicted and FEV1/FVC ratio <70%.
•Stable defined as no exacerbation in previous 3 months.
•Smoking history =10 pack-years.
•Oxygen saturations= 92% on room air at rest.
•ECG demonstrating sinus rhythm.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 9
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 9

•Uncontrolled symptoms of COPD.
•A COPD exacerbation requiring systemic steroid therapy within 3 months prior to study commencement.
•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 or average resting HR<60bpm.
•Pregnancy or lactation.
•Known or suspected sensitivity to / intolerance of IMP.
•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.

发起方

Tayside Clinical Trials Unit, University of Dundee