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ISRCTN
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ISRCTN10877141
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ClinicalTrials.gov identifier
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Public title
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Do Phosphodiesterase-5 Inhibitors improve exercise capacity in COPD patients with Pulmonary Hypertension
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Scientific title
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Do Phosphodiesterase-5 Inhibitors improve exercise capacity in COPD patients with Pulmonary Hypertension: A double-blind, randomised, placebo-controlled trial
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Acronym
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The 3Pstudy
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Serial number at source
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2008CV17
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Study hypothesis
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We hypothesise that Tadalafil, a phosphodiesterase type 5A (PDE5A) inhibitor, improves exercise capacity in those with chronic obstructive pulmonary disease (COPD) and secondary pulmonary hypertension (PH).
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Lay summary
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Ethics approval
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The North of Scotland Research Ethics Committee approved on the 9th of July 2009 (ref: 10/S0801/46)
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Study design
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Double blind randomised placebo controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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COPD with Pulmonary Hypertension
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Participants - inclusion criteria
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1. Male or female participants, aged between 35 to 85 inclusive
2. Diagnosis of COPD or Emphysema
3. Forced Expiratory Volume in one second (FEV1) <50% predicted
4. Smoker or ex-smoker with a history ≥ 20 pack years
5. Right Ventricular Systolic Pressure (RVSP) >30mmHg and/or pulmonary acceleration time <120 ms
6. Plasma Brain Natriuretic Peptide (BNP) level >25 pg/ml
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Participants - exclusion criteria
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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
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Anticipated start date
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04/09/2010
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Anticipated end date
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08/08/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet
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Target number of participants
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120
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Interventions
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We plan to do a stratified block randomisation based on their baseline Six minute walk distance (6MWD) test, the strata being <285 or ≥ 285m. They will then be randomly assigned placebo or Tadalafil 10mg once a day at for 3 months. Final follow up for all patients will be at 3 months.
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Primary outcome measure(s)
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Six minute walk distance test (6WMD) performed at baseline, 2 and 3 months
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Secondary outcome measure(s)
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1. Quality of Life
1.1. St George's Respiratory Questionnaire (SGRQ)
1.2. SF-36
1.3. Minnesota Living with Heart Failure® questionnaire (MLHFQ)
2. Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
3. B-type Natriuretic Peptide
4. Echocardiogram Measurements
Outcomes assessed at baseline, 2 and 3 months.
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Sources of funding
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Chief Scientist Office (CSO) (UK) - CSO Grant (ref: CZB/4/666)
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Trial website
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Publications
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Contact name
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Prof
Allan
Struthers
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Address
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Centre for Cardiovascular and Lung Biology
Ninewells Hospital and Medical School
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Sponsor
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University of Dundee (UK)
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Address
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College of Medicine, Dentistry and Nursing
Ninewells Hospital and Medical School
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City/town
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Dundee
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Zip/Postcode
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DD1 9SY
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Country
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United Kingdom
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Date applied
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31/08/2010
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Last edited
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19/10/2010
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Date ISRCTN assigned
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19/10/2010
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