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

Primary Purpose

Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Sildenafil
Sildenafil
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

Sildenafil 20mg

Sildenafil 40mg

Outcomes

Primary Outcome Measures

Reduction of mean PAP and PVR

Secondary Outcome Measures

CO, PaO2, V/Q

Full Information

First Posted
June 22, 2007
Last Updated
November 9, 2009
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT00491803
Brief Title
Sildenafil Effects on Pulmonary Haemodynamics and Gas Exchange in Chronic Obstructive Pulmonary Disease (COPD)
Acronym
SIL-COPD-01
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 Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
No

5. 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), 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Pulmonary Hypertension
Keywords
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Sildenafil 20mg
Arm Title
2
Arm Type
Active Comparator
Arm Description
Sildenafil 40mg
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Intervention Description
sildenafil 20 mg orally
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Intervention Description
sildenafil 40 mg orally
Primary Outcome Measure Information:
Title
Reduction of mean PAP and PVR
Time Frame
60 minutes
Secondary Outcome Measure Information:
Title
CO, PaO2, V/Q
Time Frame
60 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan albert Barbera, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19875684
Citation
Blanco I, Gimeno E, Munoz PA, Pizarro S, Gistau C, Rodriguez-Roisin R, Roca J, Barbera JA. Hemodynamic and gas exchange effects of sildenafil in patients with chronic obstructive pulmonary disease and pulmonary hypertension. Am J Respir Crit Care Med. 2010 Feb 1;181(3):270-8. doi: 10.1164/rccm.200907-0988OC. Epub 2009 Oct 29.
Results Reference
derived

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

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