Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00359736
Status:
COMPLETED
Last Update Posted:
2017-11-01
First Post:
2006-07-31
Brief Title:
Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Vasodilator Therapy and Exercise Tolerance in IPF Patients
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Medicines that decrease blood pressure in the lungs may help idiopathic pulmonary fibrosis IPF patients function better This study will test whether sildenafil improves the ability to exercise in patients with pulmonary fibrosis of unknown cause
Detailed Description:
Idiopathic pulmonary fibrosis IPF is recognized as a predominantly noninflammatory paradigm of lung fibrosis characterized by heterogeneous myofibroblast proliferation usual interstitial pneumonia UIP and a poor clinical prognosis To date no therapies have been demonstrated in well-designed randomized controlled trials RCT to favorably influence functional status or survival of IPF patients The need for effective therapies for VA patients with IPF is thus obvious and urgent
The overall goal of this VA Merit Review clinical research is to generate rigorous preliminary data for evaluation of a new and potentially effective therapy for IPF The established combined Miami Veterans Affairs Medical Center VAMC - University of Miami UM IPF program has participated productively in a number of clinical trials to assess new agents for the therapy of IPF eg interferon gamma-lb imatinib mesylate etanercept bosentan Our program is uniquely qualified to enroll large numbers of IPF patients in clinical trials because of its large metropolitan population base 5000000 people and extensive referral network throughout South and Central America The Veteran population of South Florida Dade Broward and Monroe Counties is approximately 236000 US Census Bureau Of that number 39 are 65 years of age or older making them at high risk for IPF Because of its large Veteran and civilian population base international referral network and previous experience as a high enrollment center in IPF clinical trials the Miami VAMC-UM IPF program is uniquely qualified to anticipate the role of a CSP lead center
Our central hypothesis is that sildenafil a vasodilator will have a beneficial effect compared to placebo on disease progression defined as a significant change in the 6-minute walk distance or dyspnea index in patients with IPF
Specifically we will test effects of sildenafil on IPF patients exercise tolerance and level of dyspnea in a double blind randomized placebo controlled one to one assignment pilot study Upon completion of this trial it will be possible to assess efficacy of sildenafil on progression of disease in IPF and possibly introduce this agent into translational practice Our specific objectives are
Specific Objectives 1 To assess the possible therapeutic benefit of a vasodilator sildenafil on exercise tolerance in IPF patients
The working hypothesis is that compared to placebo sildenafil will favorably affect rate of decline from baseline in exercise capacity 6-minutes walk
Specific Objective 2 To assess and compare changes from baseline in pre- and post-exercise dyspnea in sildenafil and placebo control groups
The working hypothesis is that application of this agent will lead to more sustained exercise and a more favorable clinical outcome in addition to a decrease in the degree of limiting dyspnea after exercise
The application of vasodilator therapy in IPF is unique in that it directly targets key pathophysiologic mechanisms of functional limitation Increased pulmonary vascular resistance and dyspnea due to exercise This novel approach will have a significant impact on field because it promises both additional insight into mechanisms of disease and immediate therapeutic options
The overall goal of this VA Merit Review clinical research is to generate rigorous preliminary data for evaluation of a new and potentially effective therapy for IPF The established combined Miami Veterans Affairs Medical Center VAMC - University of Miami UM IPF program has participated productively in a number of clinical trials to assess new agents for the therapy of IPF eg interferon gamma-lb imatinib mesylate etanercept bosentan Our program is uniquely qualified to enroll large numbers of IPF patients in clinical trials because of its large metropolitan population base 5000000 people and extensive referral network throughout South and Central America The Veteran population of South Florida Dade Broward and Monroe Counties is approximately 236000 US Census Bureau Of that number 39 are 65 years of age or older making them at high risk for IPF Because of its large Veteran and civilian population base international referral network and previous experience as a high enrollment center in IPF clinical trials the Miami VAMC-UM IPF program is uniquely qualified to anticipate the role of a CSP lead center
Our central hypothesis is that sildenafil a vasodilator will have a beneficial effect compared to placebo on disease progression defined as a significant change in the 6-minute walk distance or dyspnea index in patients with IPF
Specifically we will test effects of sildenafil on IPF patients exercise tolerance and level of dyspnea in a double blind randomized placebo controlled one to one assignment pilot study Upon completion of this trial it will be possible to assess efficacy of sildenafil on progression of disease in IPF and possibly introduce this agent into translational practice Our specific objectives are
Specific Objectives 1 To assess the possible therapeutic benefit of a vasodilator sildenafil on exercise tolerance in IPF patients
The working hypothesis is that compared to placebo sildenafil will favorably affect rate of decline from baseline in exercise capacity 6-minutes walk
Specific Objective 2 To assess and compare changes from baseline in pre- and post-exercise dyspnea in sildenafil and placebo control groups
The working hypothesis is that application of this agent will lead to more sustained exercise and a more favorable clinical outcome in addition to a decrease in the degree of limiting dyspnea after exercise
The application of vasodilator therapy in IPF is unique in that it directly targets key pathophysiologic mechanisms of functional limitation Increased pulmonary vascular resistance and dyspnea due to exercise This novel approach will have a significant impact on field because it promises both additional insight into mechanisms of disease and immediate therapeutic options
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None