Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

576

Participants

Timeline

Start Date

June 1, 2021

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2026

Conditions
Idiopathic Pulmonary FibrosisInterstitial Lung Disease
Interventions
DRUG

Placebo

Placebo administered QID

DRUG

Inhaled Treprostinil

Inhaled treprostinil (6 mcg/breath) administered QID

DEVICE

Treprostinil Ultrasonic Nebulizer

Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.

Trial Locations (99)

10467

Montefiore Medical Center, The Bronx

11040

Northwell Health, New Hyde Park

11725

Stony Brook Advanced Specialty Care, Stony Brook

13088

St Joseph's Physician's Pulmonary Health, Liverpool

14642

University of Rochester Medical center, Rochester

17033

Penn State Milton S. Hershey Medical Center/Penn State College of Medicine, Hershey

19104

University of Pennsylvania, Philadelphia

19107

Thoams Jefferson,Hospital University, Philadelphia

19140

Temple Lung Center, Philadelphia

20904

Adventist Healthcare White Oak Medical CEnter, Silver Spring

21224

Johns Hopkins Asthma & Allergy Center, Baltimore

22042

Inova Fairfax Hospital, Falls Church

22903

University of Virginia Health System, Charlottesville

23230

Pulmonary Associates of Richmond, Inc., Richmond

27103

Southeastern Research Center, Winston-Salem

27403

PulmonIx, LLC, Greensboro

27834

East Carolina University and Leo Jenkins Cancer Center, Greenville

29203

Prisma Health Midlands, Columbia

29425

Medical University of South Carolina, Charleston

29732

Clinical Research of Rock Hill, Rock Hill

30309

Piedmont Healthcare Atlanta, Atlanta

30322

Emory University Hospital, Atlanta

32204

Ascension St. Vincent's, Jacksonville

32209

University of Florida, Jacksonville

32224

Mayo Clinic Florida, Jacksonville

32610

University of Florida Health at Shands, Gainesville

32803

Central Florida Pulmonary Group, PA, Orlando

33331

Cleveland Clinic Florida, Weston

33606

University of South Florida Health, Tampa

33704

Coastal Pulmonary & Critical Care PLC, St. Petersburg

33765

St. Francis Sleep Allergy & Lung Institute, Clearwater

34741

Pulmonary Disease Specialists, PA d/b/a PDS Research, Kissimmee

35233

The University of Alabama at Birmingham, Birmingham

37067

Clinical Trials Center of Middle Tennessee, Franklin

37204

Vanderbilt University Medical Center, Nashville

37919

Statecare Pulmonary Consultants, Knoxville

39216

University of Mississippi Medical Center, Jackson

40202

Norton Pulmonary Specialists, Louisville

University of Louisville, Louisville

43221

The Ohio State University Wexner Medical Center - Martha Morehouse Medical Pavilion, Columbus

44195

Cleveland Clinic, Cleveland

45267

University of Cincinnati, Cincinnati

46250

Community Health Network, Indianapolis

48073

Corewell Health William Beaumont Hospital, Royal Oak

48109

University of Michigan Int Med Pulmonary and critical care, Ann Arbor

48202

Henry Ford Hospital, Detroit

53226

Medical College of Wisconsin, Milwaukee

53792

University of Wisconsin School of Medicine and Public health, Madison

55455

University of Minnesota, Minneapolis

55902

Mayo Clinic, Rochester

60153

Loyola University Medical Center, Maywood

60611

Northwestern Memorial Hospital, Chicago

60612

Rush University Medical Center Outpatient Pulmonary Clinic, Chicago

63017

The Lung Research Center, Chesterfield

63110

Washington University School of Medicine, St Louis

64111

Saint Luke's Hospital of Kansas City, Kansas City

66160

The University of Kansas Medical Center, Kansas City

68124

Creighton University Clinical Research Office, Omaha

70112

LSU Health Sciences Center New Orleans, New Orleans

Tulane University Medical Center, New Orleans

71103

LSU Health Science Center Shreveport, Shreveport

73104

University of Oklahoma Health Sciences Center, Oklahoma City

75020

Premier Pulmonary Critical Care and Sleep Medicine, Denison

75069

Metroplex Pulmonary and Sleep Center PA, McKinney

75246

Baylor University Medical Center, Dallas

77030

Baylor Clinic-Baylor College of Medicine, Houston

The University of Texas Health Science Center at Houston, Houston

77380

Renovatio Clinical Consultants, LLC, The Woodlands

78503

A & A Research Consultants, LLC, McAllen

80206

National Jewish Health, Denver

84107

Intermountain Medical Center, Murray

84108

University of Utah Health, Salt Lake City

85006

Banner University Medical Center-Phoenix, Phoenix

85012

Arizona Pulmonary Specialists, Ltd., Phoenix

85013

St. Joseph's Hospital and Medical Center - Norton Thoracic Institute, Phoenix

85724

University of Arizona, Tucson

87106

University of New Mexico Health Sciences Center, Albuquerque

90095

David Geffen School of Medicine at UCLA, Los Angeles

92037

UC San Diego Health, La Jolla

92262

Palmtree Clinical Research, Inc., Palm Springs

92663

NewportNativeMD, Inc, Newport Beach

92868

University of California, Irvine, Orange

94143

University of California - San Francisco, San Francisco

94305

Stanford University Medical Center, Stanford

95817

UC Davis Health Medical Center, Sacramento

96813

The Queen's Medical Center, Honolulu

97220

The Oregon Clinic, PC, Portland

2260000

Centro Respiratorio Integral LTDA. (CENRESIN), Quillota

7630226

Fundacion Medica San Cristobal, Santiago

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

75390-8550

Univrsity of Texas Southwestern Medical Center, Dallas

V6Z1Y6

St.Paul's Hospital, Vancouver

L1S 2J5

Dynamic Drug Advancement Limited, Ajax

L8N 4A6

St. Joseph's Healthcare Hamilton, Hamilton

M5G 2C4

Toronto General Hospital, Toronto

G1V 4G5

Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Universite, Québec

G8T 7A1

Centre d'investigation Clinique Mauricie, Trois-Rivières

Sponsors
All Listed Sponsors
lead

United Therapeutics

INDUSTRY