Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?
NCT ID: NCT01197469
Last Updated: 2012-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
120 participants
INTERVENTIONAL
2010-09-30
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo
Placebo
Tadalafil
Tadalafil
Tadalafil 10mg once daily for 3 months
Interventions
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Tadalafil
Tadalafil 10mg once daily for 3 months
Placebo
Eligibility Criteria
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Inclusion Criteria
* Forced expiratory volume in 1 second (FEV1) \<80% (FEV1/FVC \<0.70)
* Right ventricular systolic pressure (RVSP) \> 30 mmHg or Pulmonary Acceleration time \<120 ms
Exclusion Criteria
* Left ventricular ejection fraction \< 45%
* Patients taking nitrates, nicorandil or doxazosin.
* Drug contraindications:
* Systolic Blood Pressure \<90 mmHg
* recent stroke
* unstable angina
* past history of non arteritic anterior ischaemic optic neuropathy
35 Years
85 Years
ALL
No
Sponsors
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Chief Scientist Office of the Scottish Government
OTHER_GOV
NHS Tayside
OTHER_GOV
NHS Fife
OTHER_GOV
University of Dundee
OTHER
Responsible Party
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A. D. Struthers
Chief Investigator
Principal Investigators
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Allan Struthers, MBChB
Role: PRINCIPAL_INVESTIGATOR
University of Dundee
Locations
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University of Dundee
Dundee, Tayside, United Kingdom
Countries
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References
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Goudie AR, Lipworth BJ, Hopkinson PJ, Wei L, Struthers AD. Tadalafil in patients with chronic obstructive pulmonary disease: a randomised, double-blind, parallel-group, placebo-controlled trial. Lancet Respir Med. 2014 Apr;2(4):293-300. doi: 10.1016/S2213-2600(14)70013-X. Epub 2014 Mar 5.
Other Identifiers
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2008CV17
Identifier Type: -
Identifier Source: org_study_id