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

Phase 4

Completed

• Conditions: COPD; Pulmonary Hypertension
• Interventions: Other: Placebo; Drug: Sildenafil

• Registration Number: NCT01055405
• 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), the investigators hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition.

Detailed Description

It is a prospective, randomized, double-blind, placebo controlled trial to assess the effect of 3 months treatment with sildenafil (20 mg/8 h), added to a pulmonary rehabilitation program, on exercise tolerance. Subjects: 60 patients (30 by treatment group). Main end-point variable: endurance time in constant work exercise test (CWET). Other measurements: 6 min walk distance, performance in incremental exercise test, physiological and metabolic response at iso-time and iso-load in CWET, dyspnea, and health-related quality of life.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-25
• Primary Completion: 2011-03
• Study Completion: 2012-01
• Status Verified: 2012-04
• Last Update Submitted: 2012-04-03
• Last Update Posted: 2012-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo plus pulmonary rehabilitation	Placebo	-
Sildenafil plus pulmonary rehabilitation	Sildenafil	-

Primary Outcome Measures

Name	Time	Method
Endurance time	3 months

Secondary Outcome Measures

Name	Time	Method
6 min walk distance, performance in incremental exercise test, physiological and metabolic response at iso-time and iso-load in CWET, dyspnea, and health-related quality of life	3 months

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain