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OpenTrials
Completed

NCT Number: NCT01055405

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

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.

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Key information

Conditions

COPD Cardiovascular Diseases Chronic Disease Disease Attributes Hypertension Hypertension, Pulmonary Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Hypertension Respiratory Tract Diseases Vascular Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Clinic

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sildenafil

Drug

Sildenafil 20mg TID orally

Other names: Revatio

Placebo

Other

Placebo TID orally

Primary outcomes

  1. Endurance time

    Time frame: 3 months

Secondary outcomes

  1. 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

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study 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

Acronym: SIL-COPD-02

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jan 25, 2010
Registry last updated
Apr 4, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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