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

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ClinicalTrials.gov Identifier: NCT01197469
Recruitment Status : Completed
First Posted : September 9, 2010
Last Update Posted : November 6, 2012
Sponsor:
Collaborators:
Chief Scientist Office of the Scottish Government
NHS Tayside
NHS Fife
Information provided by (Responsible Party):
A. D. Struthers, University of Dundee

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Pulmonary Hypertension Drug: Tadalafil Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension?
Study Start Date : September 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Tadalafil
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Active Comparator: Tadalafil Drug: Tadalafil
Tadalafil 10mg once daily for 3 months



Primary Outcome Measures :
  1. 6 minute walking distance [ Time Frame: 3 months ]
    The investigators will perform a baseline 6 minute walking distance (0 months) and repeat the measure at 2 months and finally at 3 months


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 3 months ]
    The investigators will measure baseline quality of life (0 months) using St George's Respiratory Questionnaire, SF-36v2, Minnesota Heart Failure Questionnaire. These questionnaires will be repeated at 2 and 3 months (final measurement).

  2. B- Natriuretic Peptide (BNP) [ Time Frame: 3 months ]
    Will be measured at 0, 2 and 3 months

  3. Diffusion lung capacity for carbon monoxide (DLCO) [ Time Frame: 3 months ]
    Will be measured at 0 and 3 months

  4. Echocardiographic measurements [ Time Frame: 3 months ]
    Will be measured at 0 and 3 months



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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01197469


Locations
United Kingdom
University of Dundee
Dundee, Tayside, United Kingdom, DD1 9SY
Sponsors and Collaborators
University of Dundee
Chief Scientist Office of the Scottish Government
NHS Tayside
NHS Fife
Investigators
Principal Investigator: Allan Struthers, MBChB University of Dundee

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: A. D. Struthers, Chief Investigator, University of Dundee
ClinicalTrials.gov Identifier: NCT01197469     History of Changes
Other Study ID Numbers: 2008CV17
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: November 6, 2012
Last Verified: November 2012

Keywords provided by A. D. Struthers, University of Dundee:
Secondary Pulmonary Hypertension

Additional relevant MeSH terms:
Hypertension
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents