Study of Sildenafil Effects in Combination With Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Associated Pulmonary Hypertension

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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), the investigators hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Clinic of Barcelona
• Treatments: Sildenafil Citrate

Criteria

Inclusion Criteria:

• COPD, FEV1 < 80% ref. and FEV1/FVC < 0.7 post bronchodilator

• Age 40-80 years

• Pulmonary hypertension

• Consent to participate in the study

Exclusion Criteria:

• Pulmonary or extrapulmonary disease that modifies gas exchange or pulmonary hemodynamics

• Recent exacerbation (<4 weeks) (temporally)

• Patients treated with nitrates or CYP3A4 inhibitors (ketoconazole, itraconazole, ritonavir)

• Ischemic optic neuropathy

• Patients treated with phosphodiesterase-5 inhibitors

• Patients with ischemic cardiopathy

• Systemic disease that could modified the results

• Patients unable to practise exercise