NCT00491803

Sildenafil Effects on Pulmonary Haemodynamics and Gas Exchange in Chronic Obstructive Pulmonary Disease (COPD)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Obstructive Pulmonary Disease
• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Sildenafil	sildenafil 20 mg orally
DRUG	Sildenafil	sildenafil 40 mg orally

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-11-01
• Completion: 2009-02-01
• First posted: 2007-06-26
• Last updated: 2009-11-10

Locations

1 site across 1 country: Spain