NCT01055405

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), the investigators hypothesized that sildenafil might improve pulmonary hemodynamics and increase exercise tolerance in this condition.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 25, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 4, 2012

Status Verified

April 1, 2012

Enrollment Period

2.6 years

First QC Date

January 22, 2010

Last Update Submit

April 3, 2012

Conditions

COPDPulmonary Hypertension

Keywords

Exercise toleranceCOPDPulmonary hypertensionSildenafil

Outcome Measures

Primary Outcomes (1)

  • Endurance time

    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

    3 months

Study Arms (2)

Sildenafil plus pulmonary rehabilitation

EXPERIMENTAL
Drug: Sildenafil

Placebo plus pulmonary rehabilitation

PLACEBO COMPARATOR
Other: Placebo

Interventions

SildenafilDRUG

Sildenafil 20mg TID orally

Also known as: Revatio
Sildenafil plus pulmonary rehabilitation
PlaceboOTHER

Placebo TID orally

Placebo plus pulmonary rehabilitation

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD, FEV1 \< 80% ref. and FEV1/FVC \< 0.7 post bronchodilator
  • Age 40-80 years
  • Pulmonary hypertension
  • Consent to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinic

Barcelona, 08036, Spain

Location

Related Publications (1)

  • Blanco I, Santos S, Gea J, Guell R, Torres F, Gimeno-Santos E, Rodriguez DA, Vilaro J, Gomez B, Roca J, Barbera JA. Sildenafil to improve respiratory rehabilitation outcomes in COPD: a controlled trial. Eur Respir J. 2013 Oct;42(4):982-92. doi: 10.1183/09031936.00176312. Epub 2013 Feb 21.

    PMID: 23429918DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveHypertension, Pulmonary

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Joan Albert Barbera, MD

    Hospital Clinic of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 22, 2010

First Posted

January 25, 2010

Study Start

August 1, 2008

Primary Completion

March 1, 2011

Study Completion

January 1, 2012

Last Updated

April 4, 2012

Record last verified: 2012-04

Locations

ES(1)