Chronic obstructive pulmonary disease Pulmonary hypertension (secondary to chronic obstructive pulmonary disease) Level: LLT Classification code 10009033 Term: Contains Level: LLT Classification code 10037406 Term: Contains
Conditions
Interventions
Trade Name: Cialis
Product Name: Tadalafil (Cialis)10mg
Pharmaceutical Form: Capsule, hard
Sponsors
University of Dundee
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA Men and women age 35-85 years suffering from moderate to severe COPD (FEV1 30mmHg. The reliability of RVSP estimated from echo TR has been studied repeatedly: McGoon et al (2004) quote 10 such studies where echo RVSP correlated well with right heart catheterisations in nine out of these ten studies. Indeed, the ACCP guidelines say “In patients with a clinical suspicion of pulmonary hypertension, Doppler echocardiography should be performed to evaluate the level of RVSP”. However, RVSP is only able to be calculated in 60-70% of COPD cases and an alternative is the pulmonary acceleration time which is a measure of mean pulmonary artery pressure (MPAP). This is obtainable in 40-50% of COPD individuals in our experience. It has good reproducibility and correlates well with catheter derived measures. Prof Lipworth (co-applicant) has been using both measures for over 10 years. Cardiac output will also be assessed echocardiographically. For inclusion, patients will need to have a reduced pulmonary acceleration time (20 mmHg. Since these two echo measures should be very close, we will recruit only those with an RVSP >30 mmHg and a pulmonary acceleration time =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA Pulmonary stenosis or echo LV outflow obstruction or LV systolic dysfunction (LVEF <45%). Patients taking nitrates, nicorandil or doxazosin will also be excluded. Other standard contraindications for such drugs will apply, e.g. systolic BP <90 mmHg, recent stroke, unstable angina, past history of non arteritic anterior ischaemic optic neuropathy. With all these exclusions applied, PDE5A inhibitors such as tadalafil are regarded as safe.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Do these drugs make bronchitic patients able to walk further before they have to stop?;Secondary Objective: Do these drugs improve the quality of life of bronchitic patients?;Primary end point(s): Six minute walk test | — |
Countries
United Kingdom
Outcome results
None listed