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

Phase 4

Completed

• Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension
• Interventions: Drug: Sildenafil

• Registration Number: NCT00491803
• Lead Sponsor: Hospital Clinic of Barcelona

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-06-22
• Study First Submitted QC: 2007-06-22
• Study First Posted: 2007-06-26
• Primary Completion: 2008-11
• Study Completion: 2009-02
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-09
• Last Update Posted: 2009-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sildenafil	Sildenafil 20mg
2	Sildenafil	Sildenafil 40mg

Primary Outcome Measures

Name	Time	Method
Reduction of mean PAP and PVR	60 minutes

Secondary Outcome Measures

Name	Time	Method
CO, PaO2, V/Q	60 minutes

Trial Locations

Locations (1)

Hospital clinic; 🇪🇸 Barcelona, Spain