Sildenafil Effects on Pulmonary Haemodynamics and Gas Exchange in Chronic Obstructive Pulmonary Disease (COPD)
SIL-COPD-01
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
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 chronic-obstructive-pulmonary-disease
Started Jun 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 22, 2007
CompletedFirst Posted
Study publicly available on registry
June 26, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedNovember 10, 2009
November 1, 2009
1.4 years
June 22, 2007
November 9, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction of mean PAP and PVR
60 minutes
Secondary Outcomes (1)
CO, PaO2, V/Q
60 minutes
Study Arms (2)
1
ACTIVE COMPARATORSildenafil 20mg
2
ACTIVE COMPARATORSildenafil 40mg
Interventions
Eligibility Criteria
You may qualify if:
- COPD (FEV1/FVC\<0.7)
- Age 40-75
- Pulmonary hypertension (Vmax TI\>=2.8m/sec)
You may not qualify if:
- Treatment with CYP3A4 inhibitors, nitrates, PDE-5 inhibitors
- Coronary disease
- Ischemic optical neuritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital clinic
Barcelona, Barcelona, 08036, Spain
Related Publications (1)
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.
PMID: 19875684DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joan albert Barbera, MD
Hospital Clinic of Barcelona
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 22, 2007
First Posted
June 26, 2007
Study Start
June 1, 2007
Primary Completion
November 1, 2008
Study Completion
February 1, 2009
Last Updated
November 10, 2009
Record last verified: 2009-11