SIL-COPD-02: Study of Sildenafil Effects in Combination With Rehabilitation in Patients With Chronic Obstructive Pulmonary Disease (COPD) and Associated Pulmonary Hypertension

Sponsor

Hospital Clinic of Barcelona (Other)

Overall Status

Completed

CT.gov ID

NCT01055405

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD Pulmonary Hypertension	Drug: Sildenafil Other: Placebo	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

65 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Phase IV Study on the Effects of Sildenafil in Combination With Pulmonary Rehabilitation Program on Exercise Tolerance in Patients With COPD and Pulmonary Hypertension

Study Start Date :

Aug 1, 2008

Actual Primary Completion Date :

Mar 1, 2011

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sildenafil plus pulmonary rehabilitation	Drug: Sildenafil Sildenafil 20mg TID orally Other Names: Revatio
Placebo Comparator: Placebo plus pulmonary rehabilitation	Other: Placebo Placebo TID orally

Arm

Intervention/Treatment

Experimental: Sildenafil plus pulmonary rehabilitation

Drug: Sildenafil

Sildenafil 20mg TID orally

Other Names:

Revatio

Placebo Comparator: Placebo plus pulmonary rehabilitation

Other: Placebo

Placebo TID orally

Outcome Measures

Primary Outcome Measures

Endurance time [3 months]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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