Do phosphodiesterase-5 inhibitors improve exercise capacity in COPD patients with pulmonary hypertension?

Phase 2

Completed

Conditions: COPD with pulmonary hypertension
Signs and Symptoms
Other chronic obstructive pulmonary disease

Registration Number: ISRCTN10877141

Lead Sponsor: niversity of Dundee (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 120

Inclusion Criteria

Current inclusion criteria as of 08/10/2012:
1. Male or female participants, aged between 35 to 85 inclusive
2. COPD
3. Forced Expiratory Volume in one second (FEV1) <80% predicted (protocol change approved 18/02/2011)
4. Right Ventricular Systolic Pressure (RVSP) >30mmHg and/or pulmonary acceleration time <120 ms

Previous inclusion criteria until 08/10/2012:
1. Male or female participants, aged between 35 to 85 inclusive
2. Diagnosis of COPD or Emphysema (diagnosis of emphysema removed due to an error in the original application)
3. Forced Expiratory Volume in one second (FEV1) <50% predicted
4. Smoker or ex-smoker with a history = 20 pack years (removed due to protocol change approved 23/01/2012)
5. Right Ventricular Systolic Pressure (RVSP) >30mmHg and/or pulmonary acceleration time <120 ms
6. Plasma Brain Natriuretic Peptide (BNP) level >25 pg/ml (removed due to protocol change approved 18/02/2011)

Exclusion Criteria

1. Pulmonary stenosis
2. Echo Left Ventricular (LV) outflow obstruction
3. LV systolic dysfunction (LVEF <45%)
4. Patients taking nitrates, nicorandil or doxazosin
5. Systolic blood pressure (BP) <90 mmHg, recent stroke, unstable angina, past history of non arteritic anterior ischaemic optic neuropathy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Six-minute walk distance test (6WMD) performed at baseline, 2 and 3 months

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures as of 08/10/2012:<br>1. Quality of Life<br>1.1. St George's Respiratory Questionnaire (SGRQ)<br>1.2. SF-36<br>1.3. Minnesota Living with Heart Failure® questionnaire (MLHFQ) <br>2. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)<br>3. B-type Natriuretic Peptide<br>4. Echocardiogram Measurements<br>Outcomes assessed at baseline, 2 and 3 months with the exception of DLCO and echo which are performed at beginning and end only (protocol change approved 18/02/2011). <br><br>Previous secondary outcome measures until 08/10/2012:<br>Outcomes assessed at baseline, 2 and 3 months.