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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2017
Main ID:	NCT00517933
Date of registration:	15/08/2007
Prospective Registration:	No
Primary sponsor:	Duke University
Public title:	Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis STEP-IPF
Scientific title:	Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis
Date of first enrolment:	August 2007
Target sample size:	180
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT00517933
Study type:	Interventional
Study design:
Phase:	Phase 3

Countries of recruitment
United States

Contacts

Name:	Fernando Martinez, MD
Address:
Telephone:
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Affiliation:	University of Michigan

Name:	James Loyd, MD
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Affiliation:	Vanderbilt University

Name:	Herbert Reynolds, MD
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Affiliation:	National Heart, Lung, and Blood Institute (NHLBI)

Name:	Lake D Morrison, MD
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Affiliation:	Duke University

Name:	Joe Lasky, MD
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Telephone:
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Affiliation:	Tulane University

Name:	Gary Hunninghake, MD
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Affiliation:	University of Iowa

Name:	Ganesh Raghu, MD
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Affiliation:	University of Washington

Name:	Imre Noth, MD
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Affiliation:	University of Chicago

Name:	Kevin Anstrom, PhD
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Affiliation:	Duke University

Name:	Jay Ryu, MD
Address:
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Affiliation:	Mayo Clinic

Name:	Kevin Brown, MD
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Affiliation:	National Jewish Health

Name:	David Zisman, MD
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Affiliation:	University of California, Los Angeles

Name:	Rob Kaner, MD
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Affiliation:	Weill Medical College at Cornell University

Name:	Jesse Roman, MD
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Affiliation:	Emory University

Name:	Talmadge King, MD
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Affiliation:	University of California, San Francisco

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypertension, Pulmonary

Pulmonary Fibrosis

Intervention(s)

Other: Placebo

Drug: Sildenafil Citrate

Primary Outcome(s)

Change in 6-minute Walk Distance From Enrollment to Week 12 (= 20% Improvement) [Time Frame: Measured at Week 12]

Secondary Outcome(s)

Change in Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Adjusted Values) [Time Frame: Baseline, 12 week]

Change in Short Form Health Survey (SF36) General Health - Adjusted Value [Time Frame: Baseline, 12 weeks]

St. George's Respiratory Questionnaire (Activity Score) [Time Frame: Baseline, 6 weeks, 12 weeks]

St. George's Respiratory Questionnaire (Impacts Score) [Time Frame: Baseline, 6 weeks, 12 weeks]

Change in EuroQOL Thermometer (Adjusted Value) [Time Frame: Baseline, 12 weeks]

Change in ICECAP-O Adjusted Value [Time Frame: Baseline, 12 weeks]

6-minute Walk Distance (6MWT) [Time Frame: Baseline, 6 week, 12 week]

Change in Forced Vital Capacity (FVC) Adjusted Values [Time Frame: Baseline, Week 12]

Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance [Time Frame: Baseline, week 12]

Short Form Health Survey (SF36) General Health [Time Frame: Baseline, 6 weeks, 12 weeks]

Desaturation During 6-minute Walk Test (6MWT) [Time Frame: Week 12]

Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) [Time Frame: Baseline, Week 6, Week 12]

Change in SF36 Aggregate Physical (Adjusted Value) [Time Frame: Baseline, 12 weeks]

Change in St. George's Respiratory Questionnaire (Impacts Score) Adjusted Value [Time Frame: Baseline, 12 weeks]

Change in St. George's Respiratory Questionnaire (Total Score) (Adjusted Values) [Time Frame: Baseline, 12 week]

Forced Vital Capacity (FVC) [Time Frame: Baseline, Week 6, Week 12]

ICECAP-O [Time Frame: Baseline, 6 weeks, 12 weeks]

Short Form Health Survey (SF36) Aggregate Physical [Time Frame: Baseline, 6 weeks, 12 weeks]

Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) Adjusted Values [Time Frame: Baseline, Week 12]

EuroQOL Thermometer [Time Frame: Baseline, 6 weeks, 12 weeks]

St. George's Respiratory Questionnaire (Symptoms Score) [Time Frame: Baseline, 6 weeks, 12 weeks]

Borg Dyspnea Index (BDI) After 6 Minute Walk Test (Raw Scores) [Time Frame: Baseline, 6 week, 12 week]

Change in Dyspnea [Time Frame: Measured from enrollment to 12 weeks (phase I)]

Change in EuroQOL (EQ-5D) Utility - Adjusted Value [Time Frame: Baseline, 12 weeks]

Change in St. George's Respiratory Questionnaire (Activity Score) Adjusted Value [Time Frame: Baseline, 12 weeks]

Change in St. George's Respiratory Questionnaire (Symptoms Score) Adjusted Value [Time Frame: Baseline, 12 weeks]

EuroQOL (EQ-5D) Utility [Time Frame: Baseline, 6 weeks, 12 weeks]

University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total [Time Frame: Baseline, 6 weeks, 12 weeks]

St. George's Respiratory Questionnaire (Total Score) [Time Frame: Baseline, 6 weeks, 12 weeks]

Secondary ID(s)

Pro00018538

507

U10HL080413

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Heart, Lung, and Blood Institute (NHLBI)

Pfizer

Ethics review

Results

Results available:	Yes
Date Posted:	23/08/2013
Date Completed:
URL:	https://clinicaltrials.gov/ct2/show/results/NCT00517933

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