Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension
Conditions
Keywords
COPD
Brief summary
Sildenafil is a phosphodiesterase-5 inhibitor that has been approved for the treatment of pulmonary arterial hypertension with orphan drug designation. Sildenafil modulates the nitric oxide (NO) pathway in the vessel wall. Since this pathway is impaired in pulmonary arteries of patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD), we hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition. However, in COPD sildenafil may also impair gas exchange due to the inhibition of pulmonary hypoxic vasoconstriction. The research project is aimed to evaluate these effects. It is a prospective, randomized, double-blind study to evaluate the acute effects of a single dose of 20 or 40 mg of sildenafil on gas exchange and pulmonary hemodynamics. Subjects: 20 patients (10 in each group). Measurements: pulmonary hemodynamics, arterial blood gasses and ventilation-perfusion distributions; at rest and during sub-maximal exercise.
Interventions
DRUGSildenafil
sildenafil 20 mg orally
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* COPD (FEV1/FVC\<0.7) * Age 40-75 * Pulmonary hypertension (Vmax TI\>=2.8m/sec)
Exclusion criteria
* Treatment with CYP3A4 inhibitors, nitrates, PDE-5 inhibitors * Coronary disease * Ischemic optical neuritis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of mean PAP and PVR | 60 minutes |
Secondary
| Measure | Time frame |
|---|---|
| CO, PaO2, V/Q | 60 minutes |
Countries
Spain
Outcome results
None listed