Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Acute Effects of a Single Dose of Sildenafil (20mg/40mg) on Pulmonary Haemodynamics and Gas Exchange at Rest and During Exercise in COPD Patients With Pulmonary Hypertension
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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