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

This study has been completed.
Sponsor:
Collaborators:
Chief Scientist Office of the Scottish Government
NHS Tayside
NHS Fife
Information provided by (Responsible Party):
A. D. Struthers, University of Dundee
ClinicalTrials.gov Identifier:
NCT01197469
First received: September 1, 2010
Last updated: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension
 Drug: Tadalafil
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Do Phosphodiesterase 5A Inhibitors Improve Exercise Capacity in Patients With Chronic Obstructive Pulmonary Disease and Pulmonary Hypertension?

Resource links provided by NLM:

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

Further study details as provided by University of Dundee:

Primary Outcome Measures:
  • 6 minute walking distance [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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:
  • Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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).

  • B- Natriuretic Peptide (BNP) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Will be measured at 0, 2 and 3 months

  • Diffusion lung capacity for carbon monoxide (DLCO) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Will be measured at 0 and 3 months

  • Echocardiographic measurements [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Will be measured at 0 and 3 months


Enrollment: 120
Study Start Date: September 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Active Comparator: Tadalafil Drug: Tadalafil
Tadalafil 10mg once daily for 3 months

  Eligibility

Ages Eligible for Study:   35 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: A. D. Struthers, Chief Investigator, University of Dundee
ClinicalTrials.gov Identifier: NCT01197469     History of Changes
Other Study ID Numbers: 2008CV17
Study First Received: September 1, 2010
Last Updated: November 5, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Dundee:
Secondary Pulmonary Hypertension

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

ClinicalTrials.gov processed this record on May 23, 2013