- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00359736
Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis
Vasodilator Therapy and Exercise Tolerance in IPF Patients
Study Overview
Status
Intervention / Treatment
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 (e.g., 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 (>5,000,000 people) and extensive referral network throughout South and Central America. The Veteran population of South Florida (Dade, Broward and Monroe Counties) is approximately 236,000 (U.S. 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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33125
- VA Medical Center, Miami
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of IPF
- 40-85 years of age
- 6-minute walk distance 150-500 m
- FVC 40-90% predicted
- DLCO 30-90% predicted
Exclusion Criteria:
- Severe pulmonary hypertension
- Severe heart failure
- FEV1/FVC < 0.7
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sildenafil
Sildenafil 20 mg tid orally
|
Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
Other Names:
|
Placebo Comparator: Placebo
Identical Placebo 20 mg tid orally
|
Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in 6-minute Walk Test
Time Frame: 0 - 6 months
|
Distance in meters -- Distance (meters) walked in 6 minutes
|
0 - 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea Score (Borg Scale)
Time Frame: 0 - 6 months
|
The Dyspnea score or Borg Rating of Perceived Exertion (RPE) Scale score is a subjective rating of perceived exertion. In medicine this is used to document the patient's effort and exertion, breathlessness and fatigue during a physical test. The Dyspnea score ranges from 0 (No breathlessness at all) to 10 (Maximum or extremely strong breathlessness). IN this study the Specific Objective 2 was to assess and compare changes from baseline in pre- and post-exercise dyspnea in the sildenafil and placebo control groups. |
0 - 6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Robert M Jackson, MD, VA Medical Center, Miami
Publications and helpful links
General Publications
- Jackson RM, Glassberg MK, Ramos CF, Bejarano PA, Butrous G, Gomez-Marin O. Sildenafil therapy and exercise tolerance in idiopathic pulmonary fibrosis. Lung. 2010 Apr;188(2):115-23. doi: 10.1007/s00408-009-9209-8. Epub 2009 Dec 12.
- Jackson R, Ramos C, Gupta C, Gomez-Marin O. Exercise decreases plasma antioxidant capacity and increases urinary isoprostanes of IPF patients. Respir Med. 2010 Dec;104(12):1919-28. doi: 10.1016/j.rmed.2010.07.021. Epub 2010 Aug 23.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Fibrosis
- Hypertension
- Pulmonary Fibrosis
- Hypertension, Pulmonary
- Molecular Mechanisms of Pharmacological Action
- Vasodilator Agents
- Urological Agents
- Enzyme Inhibitors
- Phosphodiesterase Inhibitors
- Phosphodiesterase 5 Inhibitors
- Sildenafil Citrate
Other Study ID Numbers
- CLIN-009-05F
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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