EUCTR2011-006008-11-GB
Active, not recruiting
Phase 1
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 sites45 target enrollmentJuly 27, 2012
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Tayside Clinical Trials Unit, University of Dundee
- Enrollment
- 45
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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