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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01055405

Acronym

SIL-COPD-02

Enrollment

Registered

2010-01-25

Start date

2008-08-31

Completion date

2012-01-31

Last updated

2012-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Pulmonary Hypertension

Keywords

Exercise tolerance, COPD, Pulmonary hypertension, Sildenafil

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.

Interventions

DRUGSildenafil

Sildenafil 20mg TID orally

OTHERPlacebo

Placebo TID orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Endurance time	3 months

Secondary

Measure	Time frame
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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026