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

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ClinicalTrials.gov Identifier: NCT00491803
Recruitment Status : Completed
First Posted : June 26, 2007
Last Update Posted : November 10, 2009
Sponsor:
Information provided by:
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), 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 or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Pulmonary Hypertension Drug: Sildenafil Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : June 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
Sildenafil 20mg
Drug: Sildenafil
sildenafil 20 mg orally

Active Comparator: 2
Sildenafil 40mg
Drug: Sildenafil
sildenafil 40 mg orally




Primary Outcome Measures :
  1. Reduction of mean PAP and PVR [ Time Frame: 60 minutes ]

Secondary Outcome Measures :
  1. CO, PaO2, V/Q [ Time Frame: 60 minutes ]


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: November 10, 2009
Last Verified: November 2009

Keywords provided by Hospital Clinic of Barcelona:
COPD

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