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

NCT ID: NCT00491803

Last Updated: 2009-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-02-28

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.

Conditions

Chronic Obstructive Pulmonary Disease; Pulmonary Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Sildenafil 20mg

Group Type: ACTIVE_COMPARATOR

Sildenafil

Intervention Type: DRUG

sildenafil 20 mg orally

2

Sildenafil 40mg

Group Type: ACTIVE_COMPARATOR

Sildenafil

Intervention Type: DRUG

sildenafil 40 mg orally

Interventions

Sildenafil

sildenafil 20 mg orally

Intervention Type: DRUG

Sildenafil

sildenafil 40 mg orally

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: lead

Responsible Party

Hospital Clinic Barcelona

Principal Investigators

Joan albert Barbera, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic of Barcelona

Locations

Hospital clinic

Barcelona, Barcelona, Spain

Countries

Spain

References

Blanco I, Gimeno E, Munoz PA, Pizarro S, Gistau C, Rodriguez-Roisin R, Roca J, Barbera JA. Hemodynamic and gas exchange effects of sildenafil in patients with chronic obstructive pulmonary disease and pulmonary hypertension. Am J Respir Crit Care Med. 2010 Feb 1;181(3):270-8. doi: 10.1164/rccm.200907-0988OC. Epub 2009 Oct 29.

Reference Type: DERIVED

PMID: 19875684 (View on PubMed)

Other Identifiers

EudraCT #: 2007-000116-81

Identifier Type: -

Identifier Source: secondary_id

SIL-COPD-01

Identifier Type: -

Identifier Source: org_study_id