Sildenafil Effects on Pulmonary Haemodynamics and Gas Exchange in Chronic Obstructive Pulmonary Disease (COPD) (SIL-COPD-01)

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension

Treatments: Drug: Sildenafil

Study type: Interventional

Funder types: Other

Identifiers

NCT00491803

SIL-COPD-01

EudraCT #: 2007-000116-81

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

1

Active Comparator group

Description:

Sildenafil 20mg

Treatment:

Drug: Sildenafil

Drug: Sildenafil

2

Active Comparator group

Description:

Sildenafil 40mg

Treatment:

Drug: Sildenafil

Drug: Sildenafil