Sildenafil Study to Treat Idiopathic Pulmonary Fibrosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00359736
First received: July 31, 2006
Last updated: September 3, 2013
Last verified: September 2013
  Purpose

Medicines that decrease blood pressure in the lungs may help IPF patients function better. This study will test whether sildenafil improves the ability to exercise in patients with pulmonary fibrosis of unknown cause.


Condition Intervention Phase
Alveolitis, Fibrosing
Fibrosis, Pulmonary
Hypertension, Pulmonary
Drug: sildenafil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Vasodilator Therapy and Exercise Tolerance in IPF Patients

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 6-minute walk test distance (meters) after 3 and 6 months study drug [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Dyspnea (Borg scale) after 6 months study [ Time Frame: Every three months at beginning, end and follow up time point ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: July 2006
Study Completion Date: June 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Arm 1 Drug: sildenafil
Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.

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 VAMC-University of Miami 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 a vasodilator, sildenafil, 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 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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359736

Locations
United States, Florida
VA Medical Center, Miami
Miami, Florida, United States, 33125
Sponsors and Collaborators
Investigators
Principal Investigator: Robert M Jackson, MD VA Medical Center, Miami
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00359736     History of Changes
Other Study ID Numbers: CLIN-009-05F
Study First Received: July 31, 2006
Last Updated: September 3, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
alveolitis, fibrosing
exercise, aerobic
fibrosis, pulmonary
hypertension, pulmonary

Additional relevant MeSH terms:
Fibrosis
Hypertension
Hypertension, Pulmonary
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Sildenafil
Vasodilator Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 28, 2014