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OpenTrials
Completed

NCT Number: NCT01197469

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

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Cardiovascular Diseases Chronic Disease Disease Attributes Hypertension Hypertension, Pulmonary Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Dundee

Dundee, Tayside, DD1 9SY, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tadalafil

Drug

Tadalafil 10mg once daily for 3 months

Placebo

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Dundee

Other

Collaborators

  • Chief Scientist Office of the Scottish Government
  • NHS Fife
  • NHS Tayside

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 9, 2010
Registry last updated
Nov 6, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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