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

University of Dundee

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension

Treatments: Drug: Placebo; Drug: Tadalafil

Study type: Interventional

Funder types: Other

Identifiers

NCT01197469

2008CV17

Details and patient eligibility

About

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

Enrollment: 120 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Tadalafil

Active Comparator group

Treatment:

Drug: Tadalafil