Sildenafil Effects on Pulmonary Haemodynamics and Gas Exchange in Chronic Obstructive Pulmonary Disease (COPD) (SIL-COPD-01)

This study has been completed.
Sponsor:
Information provided by:
Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT00491803
First received: June 22, 2007
Last updated: November 9, 2009
Last verified: November 2009
  Purpose

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), we hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition. However, in COPD sildenafil may also impair gas exchange due to the inhibition of pulmonary hypoxic vasoconstriction. The research project is aimed to evaluate these effects.

It is a prospective, randomized, double-blind study to evaluate the acute effects of a single dose of 20 or 40 mg of sildenafil on gas exchange and pulmonary hemodynamics. Subjects: 20 patients (10 in each group). Measurements: pulmonary hemodynamics, arterial blood gasses and ventilation-perfusion distributions; at rest and during sub-maximal exercise.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
Pulmonary Hypertension
Drug: Sildenafil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Acute Effects of a Single Dose of Sildenafil (20mg/40mg) on Pulmonary Haemodynamics and Gas Exchange at Rest and During Exercise in COPD Patients With Pulmonary Hypertension

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • Reduction of mean PAP and PVR [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CO, PaO2, V/Q [ Time Frame: 60 minutes ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: June 2007
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Sildenafil 20mg
Drug: Sildenafil
sildenafil 20 mg orally
Active Comparator: 2
Sildenafil 40mg
Drug: Sildenafil
sildenafil 40 mg orally

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD (FEV1/FVC<0.7)
  • Age 40-75
  • Pulmonary hypertension (Vmax TI>=2.8m/sec)

Exclusion Criteria:

  • Treatment with CYP3A4 inhibitors, nitrates, PDE-5 inhibitors
  • Coronary disease
  • Ischemic optical neuritis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491803

Locations
Spain
Hospital clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Principal Investigator: Joan albert Barbera, MD Hospital Clinic of Barcelona
  More Information

No publications provided by Hospital Clinic of Barcelona

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Joan Albert Barbera, Hospital Clinic Barcelona
ClinicalTrials.gov Identifier: NCT00491803     History of Changes
Other Study ID Numbers: SIL-COPD-01, EudraCT #: 2007-000116-81
Study First Received: June 22, 2007
Last Updated: November 9, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Clinic of Barcelona:
COPD

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Diseases
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 21, 2014