Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis

NCT00517933

Last updated date
Study Location
University of Alabama - Birmingham
Birmingham, Alabama, 35294, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pulmonary Fibrosis, Pulmonary Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Clinical diagnosis of IPF

- Diffusing capacity of the lung (DLCO) level less than 35% (adjusted for hemoglobin)

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Current enrollment in another investigational study


- Six-minute walk distance of less than 50 meters at screening or study entry


- Difference of greater than 15% between the screening and study entry 6-minute walk
distance


- Acute or long-term impairment other than dyspnea (e.g., angina pectoris, intermittent
claudication) that limits the ability to comply with the 6-minute walk test or other
study requirements


- Forced Expiratory Volume 1-second (FEV1)/forced vital capacity (FVC) ratio of less
than 0.65 after bronchodilator use


- Extent of emphysema greater than the extent of fibrotic change (e.g., honeycombing,
reticular changes) on high-resolution computed tomography (HRCT) scan


- Acute heart attack within the 6 months prior to study entry


- Nitrate use


- Hypersensitivity to sildenafil or any component of the formulation


- Presence of aortic stenosis (AS)


- Life-threatening arrhythmia within 1 month of study entry


- Diabetes mellitus requiring insulin therapy


- Second-degree or third-degree atrioventricular (AV) block on electrocardiogram


- Severe chronic heart failure, defined by left ventricular ejection fraction (LVEF) of
less than 25%


- Presence of idiopathic hypertrophic subaortic stenosis (IHSS)


- Hypotension (i.e., systolic blood pressure [SBP] less than 100 mm Hg or diastolic
blood pressure [DBP] less than 50 mm Hg)


- Uncontrolled systemic hypertension (i.e., SBP greater than 180 mm Hg or DBP greater
than 100 mm Hg)


- Known penile deformities or conditions (e.g., sickle cell anemia, multiple myeloma,
leukemia) that may predispose participant to priapism


- Aspartate aminotransferase (AST), serum glutamic pyruvic transaminase (SGPT), alanine
aminotransferase (ALT), or serum glutamic oxaloacetic transaminase (SGOT) greater than
three times the upper limit of normal range


- Kidney impairment (i.e., creatinine clearance less than 30 mL/minute)


- Current drug or alcohol dependence


- Retinitis pigmentosa


- History of vision loss


- History of nonarteritic ischemic optic neuropathy


- Recently initiated pulmonary rehabilitation within 30 days of study entry.
Participants will be prohibited from starting pulmonary rehabilitation during the
study. Participants who are currently undergoing maintenance pulmonary rehabilitation
at study entry will be asked to maintain their levels of rehabilitation for the
duration of the study.


- Use of any investigational therapy as part of a clinical trial for any medical
condition within 30 days of study entry


- Start or change in dose of treatment for IPF investigational agent (e.g., interferon
gamma-1b, pirfenidone, etanercept, N-acetylcysteine, any other investigational agent
intended to treat IPF), corticosteroids, or cytotoxic agents within 30 days of study
entry


- Use of certain medications. More information about this criterion can be found in the
study protocol.


- Treatment for pulmonary hypertension with prostaglandins (e.g., epoprostenol,
treprostinil), endothelin-1 antagonists (e.g., bosentan, sitaxsentan, ambrisentan), or
any other phosphodiesterase inhibitor (e.g., tadalafil, vardenafil) within 30 days of
study entry


- Addition or discontinuation of calcium channel blockers, digitalis, diuretics, or
vasodilators within 30 days of study entry (dosage must be stable for 7 days prior to
study entry [except for diuretics])


- Currently on the waiting list for a lung transplant


- Use of L-arginine supplements


- Use of grapefruit juice or St. John's wort


- Pregnant or breastfeeding


- Resting saturation of peripheral oxygen (SpO2) (i.e., oxygen saturation measured using
pulse oximetry) less than 92% with 6 liters of supplemental oxygen

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Pulmonary Fibrosis, Pulmonary HypertensionSildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis
NCT00517933
  1. Birmingham, Alabama
  2. Los Angeles, California
  3. San Francisco, California
  4. Denver, Colorado
  5. Atlanta, Georgia
  6. Chicago, Illinois
  7. New Orleans, Louisiana
  8. Ann Arbor, Michigan
  9. Rochester, Minnesota
  10. New York, New York
  11. Durham, North Carolina
  12. Nashville, Tennessee
  13. Seattle, Washington
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis
Official Title  ICMJE Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis
Brief Summary Idiopathic pulmonary fibrosis (IPF) is a chronic lung disease that affects an individual's ability to breathe. This study will evaluate the effectiveness of sildenafil, a medication that increases blood flow to the lungs, at improving breathing function, exercise capacity, and quality of life in people with advanced IPF.
Detailed Description

IPF is a disease in which fibrous tissue clogs the lungs. This eventually damages air sacs in the lungs and leads to widespread and permanent scarring of lung tissue. Individuals with IPF may experience breathing difficulties, cough, chest pain, and a decreased exercise capacity. Pulmonary hypertension, which is high blood pressure in the arteries of the lungs, affects half of all people with IPF. The fibrous tissue that clogs the lungs also blocks blood from flowing through the lungs effectively, reducing the amount of oxygen in the lungs. The fibrous tissue also reduces the lungs' ability to use what oxygen is available. These factors can cause breathing difficulties and may eventually lead to heart disease. Sildenafil is a medication that can increase blood supply to the lungs and reduce the heart's workload. The purpose of this study is to evaluate the effectiveness of sildenafil at improving breathing function, exercise capacity, and quality of life in people with advanced IPF.

This study will enroll people with advanced IPF. Participants will be randomly assigned to receive sildenafil or placebo three times a day for 12 weeks. Study visits will occur at baseline and Weeks 1, 6, and 12. At Week 12, participants will have the option to continue in the study for an additional 12 weeks. All participants who agree to continue in the study will receive sildenafil three times a day for the second 12 weeks. Study visits will occur at Weeks 13, 18, and 24. At all study visits, a physical exam and blood collection will occur. At selected visits, the following study procedures will occur: lung function testing; urine collection; a 6-minute walk test, which will measure the distance walked in a 6-minute period; and questionnaires to assess health status, breathing, and quality of life. Participants will record medication usage and symptoms in a daily diary. Study researchers will review medical records and the Social Security death index 5 years following the end of the study to determine the incidence of death among study participants.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pulmonary Fibrosis
  • Hypertension, Pulmonary
Intervention  ICMJE
  • Drug: Sildenafil Citrate
    Sildenafil citrate (20mg 3 times a day [TID] orally for 12 weeks followed by 20mg TID open-label sildenafil for an additional 12 weeks)
    Other Name: Revatio
  • Other: Placebo
    Placebo (20mg TID orally for 12 weeks followed by 20mg open-label sildenafil for 12 weeks)
Study Arms  ICMJE
  • Active Comparator: Sildenafil
    20 mg of sildenafil 3 times a day (TID) for 12 weeks followed by 20 mg of sildenafil TID for an additional 12 weeks
    Intervention: Drug: Sildenafil Citrate
  • Placebo Comparator: Placebo / Sildanafil
    20 mg of placebo TID for 12 weeks followed by 20 mg of sildenafil citrate TID for an additional 12 weeks
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2009)
180
Original Estimated Enrollment  ICMJE
 (submitted: August 15, 2007)
170
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of IPF
  • Diffusing capacity of the lung (DLCO) level less than 35% (adjusted for hemoglobin)

Exclusion Criteria:

  • Current enrollment in another investigational study
  • Six-minute walk distance of less than 50 meters at screening or study entry
  • Difference of greater than 15% between the screening and study entry 6-minute walk distance
  • Acute or long-term impairment other than dyspnea (e.g., angina pectoris, intermittent claudication) that limits the ability to comply with the 6-minute walk test or other study requirements
  • Forced Expiratory Volume 1-second (FEV1)/forced vital capacity (FVC) ratio of less than 0.65 after bronchodilator use
  • Extent of emphysema greater than the extent of fibrotic change (e.g., honeycombing, reticular changes) on high-resolution computed tomography (HRCT) scan
  • Acute heart attack within the 6 months prior to study entry
  • Nitrate use
  • Hypersensitivity to sildenafil or any component of the formulation
  • Presence of aortic stenosis (AS)
  • Life-threatening arrhythmia within 1 month of study entry
  • Diabetes mellitus requiring insulin therapy
  • Second-degree or third-degree atrioventricular (AV) block on electrocardiogram
  • Severe chronic heart failure, defined by left ventricular ejection fraction (LVEF) of less than 25%
  • Presence of idiopathic hypertrophic subaortic stenosis (IHSS)
  • Hypotension (i.e., systolic blood pressure [SBP] less than 100 mm Hg or diastolic blood pressure [DBP] less than 50 mm Hg)
  • Uncontrolled systemic hypertension (i.e., SBP greater than 180 mm Hg or DBP greater than 100 mm Hg)
  • Known penile deformities or conditions (e.g., sickle cell anemia, multiple myeloma, leukemia) that may predispose participant to priapism
  • Aspartate aminotransferase (AST), serum glutamic pyruvic transaminase (SGPT), alanine aminotransferase (ALT), or serum glutamic oxaloacetic transaminase (SGOT) greater than three times the upper limit of normal range
  • Kidney impairment (i.e., creatinine clearance less than 30 mL/minute)
  • Current drug or alcohol dependence
  • Retinitis pigmentosa
  • History of vision loss
  • History of nonarteritic ischemic optic neuropathy
  • Recently initiated pulmonary rehabilitation within 30 days of study entry. Participants will be prohibited from starting pulmonary rehabilitation during the study. Participants who are currently undergoing maintenance pulmonary rehabilitation at study entry will be asked to maintain their levels of rehabilitation for the duration of the study.
  • Use of any investigational therapy as part of a clinical trial for any medical condition within 30 days of study entry
  • Start or change in dose of treatment for IPF investigational agent (e.g., interferon gamma-1b, pirfenidone, etanercept, N-acetylcysteine, any other investigational agent intended to treat IPF), corticosteroids, or cytotoxic agents within 30 days of study entry
  • Use of certain medications. More information about this criterion can be found in the study protocol.
  • Treatment for pulmonary hypertension with prostaglandins (e.g., epoprostenol, treprostinil), endothelin-1 antagonists (e.g., bosentan, sitaxsentan, ambrisentan), or any other phosphodiesterase inhibitor (e.g., tadalafil, vardenafil) within 30 days of study entry
  • Addition or discontinuation of calcium channel blockers, digitalis, diuretics, or vasodilators within 30 days of study entry (dosage must be stable for 7 days prior to study entry [except for diuretics])
  • Currently on the waiting list for a lung transplant
  • Use of L-arginine supplements
  • Use of grapefruit juice or St. John's wort
  • Pregnant or breastfeeding
  • Resting saturation of peripheral oxygen (SpO2) (i.e., oxygen saturation measured using pulse oximetry) less than 92% with 6 liters of supplemental oxygen
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00517933
Other Study ID Numbers  ICMJE Pro00018538
U10HL080413 ( U.S. NIH Grant/Contract )
507
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Pfizer
Investigators  ICMJE
Study Chair:Gary Hunninghake, MDUniversity of Iowa
Principal Investigator:Kevin Brown, MDNational Jewish Health
Principal Investigator:Rob Kaner, MDWeill Medical College at Cornell University
Principal Investigator:Talmadge King, MDUniversity of California, San Francisco
Principal Investigator:Joe Lasky, MDTulane University
Principal Investigator:James Loyd, MDVanderbilt University
Principal Investigator:Fernando Martinez, MDUniversity of Michigan
Principal Investigator:Imre Noth, MDUniversity of Chicago
Principal Investigator:Ganesh Raghu, MDUniversity of Washington
Principal Investigator:Jesse Roman, MDEmory University
Principal Investigator:Jay Ryu, MDMayo Clinic
Principal Investigator:David Zisman, MDUniversity of California, Los Angeles
Principal Investigator:Kevin Anstrom, PhDDuke University
Study Director:Herbert Reynolds, MDNational Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator:Lake D Morrison, MDDuke University
PRS Account Duke University
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP