NCT00517933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

13 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

August 23, 2013

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

1.8 years

First QC Date

August 15, 2007

Results QC Date

November 5, 2010

Last Update Submit

June 22, 2015

Conditions

Pulmonary FibrosisHypertension, Pulmonary

Keywords

Idiopathic Pulmonary FibrosisPulmonary Hypertension

Outcome Measures

Primary Outcomes (1)

  • Change in 6-minute Walk Distance From Enrollment to Week 12 (≥ 20% Improvement)

    This is a binary score (1 or 0) with 1 being better than 0. All models adjust for baseline values of age, height, sex, white race, and DLCO. Values from models are estimated changes from baseline to 12 weeks (with 95% confidence intervals). The difference estimate is based on sildenafil - placebo.

    Measured at Week 12

Secondary Outcomes (29)

  • 6-minute Walk Distance (6MWT)

    Baseline, 6 week, 12 week

  • Estimated Change From Baseline to 12 Weeks in 6-minute Walk Distance

    Baseline, week 12

  • Desaturation During 6-minute Walk Test (6MWT)

    Week 12

  • Change in Dyspnea

    Measured from enrollment to 12 weeks (phase I)

  • University of California at San Diego (UCSD) Shortness of Breath Questionnaire Total

    Baseline, 6 weeks, 12 weeks

  • +24 more secondary outcomes

Study Arms (2)

Sildenafil

ACTIVE COMPARATOR

20 mg of sildenafil 3 times a day (TID) for 12 weeks followed by 20 mg of sildenafil TID for an additional 12 weeks

Drug: Sildenafil Citrate

Placebo / Sildanafil

PLACEBO COMPARATOR

20 mg of placebo TID for 12 weeks followed by 20 mg of sildenafil citrate TID for an additional 12 weeks

Other: Placebo

Interventions

Sildenafil CitrateDRUG

Sildenafil citrate (20mg 3 times a day \[TID\] orally for 12 weeks followed by 20mg TID open-label sildenafil for an additional 12 weeks)

Also known as: Revatio
Sildenafil
PlaceboOTHER

Placebo (20mg TID orally for 12 weeks followed by 20mg open-label sildenafil for 12 weeks)

Placebo / Sildanafil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California - Los Angeles

Los Angeles, California, 90095, United States

Location

University of California - San Francisco

San Francisco, California, 94110, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Tulane University

New Orleans, Louisiana, 70118, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

University of Washington

Seattle, Washington, 98165, United States

Location

Related Publications (3)

  • Andrade J, Schwarz M, Collard HR, Gentry-Bumpass T, Colby T, Lynch D, Kaner RJ; IPFnet Investigators. The Idiopathic Pulmonary Fibrosis Clinical Research Network (IPFnet): diagnostic and adjudication processes. Chest. 2015 Oct;148(4):1034-1042. doi: 10.1378/chest.14-2889.

    PMID: 26111071DERIVED

  • Durheim MT, Collard HR, Roberts RS, Brown KK, Flaherty KR, King TE Jr, Palmer SM, Raghu G, Snyder LD, Anstrom KJ, Martinez FJ; IPFnet investigators. Association of hospital admission and forced vital capacity endpoints with survival in patients with idiopathic pulmonary fibrosis: analysis of a pooled cohort from three clinical trials. Lancet Respir Med. 2015 May;3(5):388-96. doi: 10.1016/S2213-2600(15)00093-4. Epub 2015 Apr 15.

    PMID: 25890798DERIVED

  • Idiopathic Pulmonary Fibrosis Clinical Research Network; Zisman DA, Schwarz M, Anstrom KJ, Collard HR, Flaherty KR, Hunninghake GW. A controlled trial of sildenafil in advanced idiopathic pulmonary fibrosis. N Engl J Med. 2010 Aug 12;363(7):620-8. doi: 10.1056/NEJMoa1002110. Epub 2010 May 18.

    PMID: 20484178DERIVED

Related Links

MeSH Terms

Conditions

Pulmonary FibrosisHypertension, PulmonaryIdiopathic Pulmonary Fibrosis

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Lung Diseases, InterstitialLung DiseasesRespiratory Tract DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsHypertensionVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

Findings are limited to patients with advanced IPF. It is unknown if treatment effect was driven by particular subgroup of patients. Study was too short and enrolled too few to assess duration of effect.

Results Point of Contact

Title
Kevin J Anstrom, PhD
Organization
Duke Clinical Research Institute
kevin.anstrom@duke.edu
919-668-8902

Study Officials

  • Gary Hunninghake, MD

    University of Iowa

    STUDY CHAIR

  • Kevin Brown, MD

    National Jewish Health

    PRINCIPAL INVESTIGATOR

  • Rob Kaner, MD

    Weill Medical College at Cornell University

    PRINCIPAL INVESTIGATOR

  • Talmadge King, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

  • Joe Lasky, MD

    Tulane University

    PRINCIPAL INVESTIGATOR

  • James Loyd, MD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

  • Fernando Martinez, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Imre Noth, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

  • Ganesh Raghu, MD

    University of Washington

    PRINCIPAL INVESTIGATOR

  • Jesse Roman, MD

    Emory University

    PRINCIPAL INVESTIGATOR

  • Jay Ryu, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • David Zisman, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

  • Kevin Anstrom, PhD

    Duke University

    PRINCIPAL INVESTIGATOR

  • Herbert Reynolds, MD

    National Heart, Lung, and Blood Institute (NHLBI)

    STUDY DIRECTOR

  • Lake D Morrison, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2007

First Posted

August 17, 2007

Study Start

August 1, 2007

Primary Completion

May 1, 2009

Study Completion

October 1, 2009

Last Updated

June 24, 2015

Results First Posted

August 23, 2013

Record last verified: 2015-06

Locations

US(13)