Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?

Brief Title

Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Pulmonary Hypertension?

Official Title

Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension?

Brief Summary

      The investigators hypothesise that phosphodiesterase 5A inhibitors will improve exercise
      capacity in those with Chronic Obstructive Pulmonary Disease and secondary pulmonary
      hypertension.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

6 minute walking distance

Secondary Outcome

 Quality of Life

Condition

Chronic Obstructive Pulmonary Disease

Intervention

Tadalafil

Study Arms / Comparison Groups

 Placebo
Description:  Placebo

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

120

Start Date

September 2010

Completion Date

September 2012

Primary Completion Date

September 2012

Eligibility Criteria

        Inclusion Criteria:

          -  COPD

          -  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:

          -  Pulmonary stenosis or echo left ventricular outflow tract obstruction

          -  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
      

Gender

All

Ages

35 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Allan Struthers, MBChB, , 

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations


NCT ID

NCT01197469

Organization ID

2008CV17


Responsible Party

Principal Investigator

Study Sponsor

University of Dundee

Collaborators

 Chief Scientist Office of the Scottish Government

Study Sponsor

Allan Struthers, MBChB, Principal Investigator, University of Dundee


Verification Date

November 2012