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Clinical Trials/EUCTR2011-006008-11-GB
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.

Registry
who.int
Start Date
July 27, 2012
End Date
July 21, 2016
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Sponsor
Tayside Clinical Trials Unit, University of Dundee

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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