Safety and Efficacy of Inhaled Treprostinil in Adult PH With ILD Including CPFE

Purpose

This is a multicenter, randomized (1:1 inhaled treprostinil: placebo), double-blinded, placebo-controlled trial to evaluate the safety and efficacy of inhaled treprostinil in subjects with pre-capillary pulmonary hypertension (PH) associated with interstitial lung disease (ILD) including combined pulmonary fibrosis and emphysema (CPFE). The study will include about 314 patients at approximately 120 clinical trial centers. The treatment phase of the study will last approximately 16 weeks. Patients who complete all required assessments will also be eligible to enter an open-label, extension study (RIN-PH-202).

Conditions

  • Pulmonary Hypertension
  • Interstitial Lung Disease
  • Combined Pulmonary Fibrosis and Emphysema

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Subject voluntarily gives informed consent to participate in the study.
  2. Males and females aged 18 years or older at the time of informed consent.

a. Females of reproductive potential must be non-pregnant (as confirmed by a urine pregnancy test at screening) and non-lactating, and will: i. Either abstain from intercourse (when it is in line with their preferred and usual lifestyle), or ii. Use two medically acceptable, highly-effective forms of contraception for the duration of study, and at least 30 days after discontinuing study drug.

b. Males with a partner of childbearing potential must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.

3. The subject has a confirmed diagnosis of WHO Group 3 PH based on CT imaging, which demonstrates evidence of diffuse parenchymal lung disease performed within 6 months prior to randomization. Subjects may have any form of ILD or CPFE.

4. Subjects are required to have a right heart catheterization (RHC) within one year prior to randomization with the following documented parameters:

1. Pulmonary vascular resistance (PVR) > 3 Wood Units (WU) and

2. A pulmonary capillary wedge pressure (PCWP) of < 15 mmHg and and

3. A mean pulmonary arterial pressure (mPAP) of ≥ 25 mmHg

5. Baseline 6MWD ≥ 100 meters

6. Subjects on a chronic medication for underlying lung disease (ie, pirfenidone, nintedanib, etc) must be on a stable and optimized dose for ≥ 30 days prior to randomization. Subjects receiving pirfenidone or nintedanib must have been receiving treatment for at least 90 days and on a stable dose for at least 30 days prior to randomization.

7. In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing and likely to be cooperative with protocol requirements, including attending all study visits.

8. Subjects with connective tissue disease (CTD) must have a Baseline FVC of < 70%.

Exclusion Criteria

  1. The subject has a diagnosis of pulmonary arterial hypertension (PAH) or PH for reasons other than WHO Group 3 PH-ILD as outlined in inclusion criterion 3.
  2. The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation or inability to effectively titrate that therapy.
  3. The subject has received any PAH approved therapy including: prostacyclin therapy (i.e., epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), IP receptor agonist (selexipag), endothelin receptor antagonist (ERA), phosphodiesterase type 5 inhibitor (PDE-5I), or soluble guanylate cyclase (sGC) within 60 days of randomization.
  4. The subject has evidence of clinically significant left-sided heart disease as defined by:
  5. PCWP > 15 mmHg
  6. Left ventricular ejection fraction < 40%.

Note: Subjects with abnormal left ventricular function attributable entirely to impaired left ventricular filling due to the effects of right ventricular overload (i.e., right ventricular hypertrophy and/or dilatation) will not be excluded.

5. The subject is receiving > 10 L/min of oxygen supplementation by any mode of delivery at rest at Baseline.

6. Current use of any inhaled tobacco/marijuana products or significant history of drug abuse at the time of informed consent.

7. Exacerbation of underlying lung disease or active pulmonary or upper respiratory infection within 30 days of randomization.

8. Initiation of pulmonary rehabilitation within 12 weeks prior to the randomization.

9. In the opinion of the Investigator, the subject has any condition that would interfere with the interpretation of study assessments or has any disease or condition (ie, peripheral vascular disease, musculoskeletal disorder, morbid obesity) that would likely be the primary limit to ambulation (as opposed to PH).

10. Use of any investigational drug/device, or participation in any investigational study with therapeutic intent within 30 days prior to randomization.

11. Severe concomitant illness limiting life expectancy (< 6 months).

12. Acute pulmonary embolism within 90 days of randomization.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Placebo Comparator
Placebo
Matching placebo inhaled using an ultrasonic nebulizer four times daily
  • Drug: Placebo
    Placebo administered four times daily
Active Comparator
Active Inhaled Treprostinil
Active Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled four times daily and titrated up to a maximum of 12 breaths four times daily
  • Drug: Inhaled Treprostinil
    Inhaled treprostinil (6 mcg/breath) administered four times daily
    Other names:
    • Tyvaso

Recruiting Locations

Trials Today and nearby locations

NYU Langone Medical Center
New York, New York 10016
Contact:
Anabela Barroso
212-263-1260
Anabela.barroso@nyulangone.org

The Mount Sinai Hospital
New York, New York 10029
Contact:
Elizabeth Tinuoye
212-241-7403
elizabeth.tinuoye@mountsinai.org

Northwell Health
New Hyde Park, New York 11040
Contact:
Sameer Verma, MD
516-465-5437
SVerma3@northwell.edu

Pulmonary Health Physicians, PC
Fayetteville, New York 13066
Contact:
Jeannine Moore
315-234-0823
Jeannine.moore@cnylungs.com

New York Methodist Hospital
Brooklyn, New York 11215
Contact:
Christina Edwards
718-780-5906
che2018@nyp.org

Weill Cornell Medical Center
New York, New York 10065
Contact:
Katelyn Bastert
212-746-2698
kab4007@med.cornell.edu

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
Contact:
Dakota Buhrman
919-445-0353
dakota_buhrman@med.unc.edu

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
Contact:
Xiuhua Yuan
216-844-2371
Xiuhua.Yuan@UHhospitals.com

The Carl and Edyth Lindner Research Center at The Christ Hospital
Cincinnati, Ohio 45219
Contact:
Christine Lawrence, RN
513-585-1777
christine.lawrence@thechristhospital.com

Pinehurst Medical Clinic, Inc.
Pinehurst, North Carolina 28374
Contact:
Rebecca Meyer
910-235-3144
Rmeyer@pinehurstmedical.com

Duke University Medical Center
Durham, North Carolina 27710
Contact:
Susana Almeida-Peters, BN,RN
919-668-2642
susana.almeida-peters@duke.edu

Albany Medical College
Albany, New York 12208
Contact:
Rachel Vancavage, MPH
518-262-6608
vancavr@amc.edu

The University of New Mexico
Albuquerque, New Mexico 87131
Contact:
Hunter Esmiol
505-272-6511
huesmiol@salud.unm.edu

Spectrum Health Medical Center
Grand Rapids, Michigan 49503
Contact:
Mona Wojtas
616-486-2054
mona.wojtas@spectrumhealth.org

Brigham & Women's Hospital
Boston, Massachusetts 02115
Contact:
Mariana Urbina
617-732-4954
mfariaurbina@bwh.harvard.edu

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Kelsey Brait
617-726-3289
kbrait@mgh.harvard.edu

Tufts Medical Center
Boston, Massachusetts 02111
Contact:
Mary Hays
617-636-1334
mhays@tuftsmedicalcenter.org

University of Minnesota
Minneapolis, Minnesota 55455
Contact:
Gretchen Peichel
612-626-6237
gpeichel@umn.edu

Mayo Clinic
Rochester, Minnesota 55905
Contact:
Sue Donlinger
Donlinger.sueann@mayo.edu

Saint Mary's Regional Medical Center
Reno, Nevada 89503
Contact:
Jami-Sue Coleman, PhD
jcoleman@primehealthcare.com

Washington University School of Medicine
Saint Louis, Missouri 63110
Contact:
Sharon Heuerman, RN
314-747-8174
sheuerman@wustl.edu

Saint Luke's Hospital of Kansas City
Kansas City, Missouri 64111
Contact:
Roseann Gans
816-932-6122
rgans@saint-lukes.org

University of Mississippi Medical Center
Jackson, Mississippi 39216
Contact:
Alycia Harris
601-815-3070
aharris3@umc.edu

Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Mary Beukemann
216-444-2140
beukemm@ccf.org

Integris Baptist Medical Center
Oklahoma City, Oklahoma 73112
Contact:
Kristin Mund
405-713-4413
kristin.mund@integrisok.com

Inova Fairfax Hospital
Fairfax, Virginia 22042
Contact:
Priscila Dauphin, MD
703-776-7128
priscila.dauphin@inova.org

Sentara Cardiovascular Research Institute
Norfolk, Virginia 23507
Contact:
Melinda Bullivant
757-388-4024
MMBULLIV@sentara.com

University of Vermont, Vermont Lung Center
Colchester, Vermont 05446
Contact:
Chloe Housenger
802-847-9803
Chloe.Housenger@uvmhealth.org

The University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Contact:
Krisitn Rocchi
830-320-0101
rocchi@uthscsa.edu

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Mary Rangel
713-500-6851
mary.rangel@uth.tmc.edu

Pulmonary Associates of Richmond
Richmond, Virginia 23229
Contact:
Betsy Daniel
bdaniel@paraccess.com

University of Washington Medical Center
Seattle, Washington 98195
Contact:
Chessa Goss
206-258-9014
cagoss@uw.edu

Alliance Cardio Pulmonary Research Group, Inc.
Guaynabo, Puerto Rico 00968
Contact:
Jessenia Santos
787-459-4238
jnavedo@insitu.global

Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin 53226
Contact:
Ashley Wuerl
414-955-6211
awuerl@mcw.edu

Aurora St. Luke's Medical Center
Milwaukee, Wisconsin 53215
Contact:
Linda Boehm, RN
414-649-5664
linda.boehm@aurora.org

University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin 53792
Contact:
Lori Wollet
608-263-0524
ljwollet@medicine.wisc.edu

Michael E. DeBakey VA Medical Center
Houston, Texas 77030
Contact:
Sarah Perusich
713-794-7294
Sarah.Perusich@va.gov

Houston Methodist
Houston, Texas 77030
Contact:
Taniqua Warren, LVN
713-363-9280
tvwarren@houstonmethodist.org

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
Contact:
Anthony Wesolowski
412-692-2263
wesolowskiap2@upmc.edu

Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Contact:
Joan Rossi, RN
412-359-3293
joan.rossi@ahn.org

Hospital of University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Randi Goodman
215-294-9758
randi.goodman@uphs.upenn.edu

Lancaster General Health
Lancaster, Pennsylvania 17603
Contact:
Lou Anne Kruse, RN, BSN
717-544-1777
lakruse@LGHealth.org

AnMed Health Pulmonary and Sleep Medicine
Anderson, South Carolina 29621
Contact:
Veronica Thrasher
864-512-3360
veronica.thrasher@anmedhealth.org

Medical University of South Carolina
Charleston, South Carolina 29425
Contact:
Nadine O'Connor
843-792-6890
oconnorn@musc.edu

Texas Tech University Health Sciences Center
El Paso, Texas 79905
Contact:
Hayder Azeez
972-388-6629
Hayder.Azeez@ttuhsc.edu

UT Southwestern Medical Center
Dallas, Texas 75390
Contact:
Oluwatosin Igenoza
214-645-9730
Oluwatosin.Igenoza@UTSouthwestern.edu

Baylor University Medical Center at Dallas
Dallas, Texas 75246
Contact:
Victoria Flores
214-820-9888
Victoria.Flores@BSWHealth.org

Statcare Pulmonary Consultants
Knoxville, Tennessee 37919
Contact:
Kim Puccio, LPN
865-934-2676
kim.puccio@biomed-research.com

Johns Hopkins University
Baltimore, Maryland 21205
Contact:
Dezeray Cephas
410-502-4362
dcephas1@jhu.edu

University of Maryland Medical Center
Baltimore, Maryland 21201
Contact:
Lioubov Poliakova
410-328-6885
lpoliako@medicine.umaryland.edu

Georgetown University Hospital
Washington, District of Columbia 20007
Contact:
Amen Hamed
202-444-0895
amen.hamed@gunet.georgetown.edu

MedStar Heart & Vascular Institute
Washington, District of Columbia 20010
Contact:
Hellina Birru
202-877-5902
Hellina.t.birru@medstar.net

National Jewish Health
Denver, Colorado 80206
Contact:
Kris Eliopoulos
303-270-2622
eliopoulosk@njhealth.org

University of Colorado Hospital - Cardiac and Vascular Center
Aurora, Colorado 80045
Contact:
Cheryl Abbott, RN, CCRP
303-724-7466
cheryl.abbott@CUAnschutz.edu

University of California San Francisco
San Francisco, California 94143
Contact:
Darren Leong
415-353-2296
darren.leong@ucsf.edu

Florida Lung, Asthma & Sleep Specialists, P.A.
Celebration, Florida 34747
Contact:
Dadllany Castaneda
407-507-2615
dadllany@floridalungdoctors.com

University of Florida Clinical Research Center
Gainesville, Florida 32610
Contact:
Christina Eagan, RN
352-273-8990
christina.eagan@medicine.ufl.edu

Miami VA Medical Center
Miami, Florida 33125
Contact:
Gisel Urdaneta
305-575-7000
Gisel.urdanetaCestary@va.gov

St. Vincent's Lung, Sleep, and Critical Care Specialists
Jacksonville, Florida 33204
Contact:
Minal Patel
904-450-8255
Minal.Patel@ascension.org

Mayo Clinic Jacksonville
Jacksonville, Florida 32224
Contact:
Inna Abrea
Abrea.Inna@mayo.edu

University of Florida College of Medicine, Jacksonville
Jacksonville, Florida 32209
Contact:
Fallon Wainwright
904-244-1106
fallon.wainwright@jax.ufl.edu

Kaiser Permanente
San Francisco, California 94115
Contact:
Quyen Chau
quyen.x.chau@kp.org

Kaiser Permanente - Roseville
Roseville, California 95825
Contact:
Renee Cunanan
916-973-4885
Renee.J.Cunanan@kp.org

Cedars-Sinai Medical Center
Beverly Hills, California 90211
Contact:
Bonnie Garcia
310-248-7141
bonnie.garcia@cshs.org

University of Arizona
Tucson, Arizona 85724
Contact:
Valerie Bloss
520-626-8305
vbloss@email.arizona.edu

Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona 85012
Contact:
Nidhi Samaraweera
602-271-0832
nidhi-research@hotmail.com

IMC-Diagnostic & Medical Clinic
Mobile, Alabama 36604
Contact:
Deborah Barnett
251-435-1651
deborah.barnett@infirmaryhealth.org

University of California San Francisco - Fresno
Fresno, California 93701
Contact:
Sonia Garcia
559-499-6637
sgarcia@fresno.ucsf.edu

University of California San Diego
La Jolla, California 92093
Contact:
Colton Carter
858-657-7122
cjcarter@ucsd.edu

Pacific Pulmonary Medical Group
Riverside, California 92505
Contact:
Mostafa Elsiah
951-373-5827
mostafa.ppmg@gmail.com

Department of Veterans Affairs Greater Los Angeles Healthcare System
Los Angeles, California 90073
Contact:
Harold Te
310-268-4314
harold.te@va.gov

University of Southern California
Los Angeles, California 90033
Contact:
Anton Akulov, MD
323-409-7594
anton.akulov@med.usc.edu

VA Long Beach Healthcare System
Long Beach, California 90822
Contact:
Gelincik Orakcilar
562-826-8000
gelincik.orakcilar@va.gov

University of Miami
Miami, Florida 33136
Contact:
Emilia Faraj
305-243-9383
enf16@med.miami.edu

Central Florida Pulmonary Group, P.A.
Orlando, Florida 32803
Contact:
Sharon Foust
sfoust@cfpulmonary.com

St. Vincent Medical Group, Inc.
Indianapolis, Indiana 46260
Contact:
Diane Slama, RN
317-338-6717
diane.slama@ascension.org

University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
Contact:
Cynthia Larew
319-353-7953
cynthia-larew@uiowa.edu

Community Heart and Vascular Hospital
Indianapolis, Indiana 46250
Contact:
Joanna Greene-Nashold, RN
317-621-8629
jgnashold@ecommunity.com

Indiana University Hospital
Indianapolis, Indiana 46202
Contact:
Melissa Astin, RN
317-962-2072
mastin@iuhealth.org

Lutheran Medical Group
Fort Wayne, Indiana 46804
Contact:
Amanda Lutter
260-460-7112
alutter@lhn.net

University of Kansas Medical Center
Kansas City, Kansas 66160
Contact:
Luigi Boccardi
913-945-4022
lboccardi@kumc.edu

University of Kentucky Medical Center
Lexington, Kentucky 40536
Contact:
Christian Soares
859-218-6740
cso232@uky.edu

Maine Medical Center
South Portland, Maine 04106
Contact:
Carol Bair
207-828-1122
cbair@cmamaine.com

Louisiana State University Health Sciences Center New Orleans
New Orleans, Louisiana 70112
Contact:
Paula Lauto, RN
504-568-3451
plauto@lsuhsc.edu

University of Louisville Physicians Outpatient Center
Louisville, Kentucky 40202
Contact:
Joan Hamlyn
502-852-8739
Joan.hamlyn@louisville.edu

Kentuckiana Pulmonary Associates
Louisville, Kentucky 40202
Contact:
Martha Royse, APRN
502-587-8000
roysenp@gmail.com

Loyola University Medical Center
Maywood, Illinois 60153
Contact:
Flip Wilk
708-216-2028
fwilk@luc.edu

University of Chicago Medical Center
Chicago, Illinois 60637
Contact:
Sandy Coslet

Cleveland Clinic Florida
Weston, Florida 33331
Contact:
Maria Briceno, MD
954-659-6409
bricenm@ccf.org

University of South Florida
Tampa, Florida 33606
Contact:
Amanda Lett
813-844-7647
alett@tgh.org

South Miami Heart Specialists
South Miami, Florida 33143
Contact:
Jojie Calderin
305-999-3301
gcalderin@ampmrc.com

Florida Hospital
Orlando, Florida 32804
Contact:
Kimberly Cawthon
407-303-7556
Kimberly.Cawthon@AdventHealth.com

The Emory Clinic
Atlanta, Georgia 30322
Contact:
Jane Gillespie, RN
404-712-8204
jegille@emory.edu

Piedmont - Georgia Lung Associates
Austell, Georgia 30106
Contact:
Elizabeth Wilkins
elizabeth.wilkins@piedmont.org

University of Illinois at Chicago Hospital
Chicago, Illinois 60612
Contact:
Jennifer Afuko
312-355-5895
jakufo2@uic.edu

Rush University Medical Center
Chicago, Illinois 60612
Contact:
Joyce Brown, RN
312-942-6771
Joyce_D_Brown@rush.edu

Wellstar Medical Group
Marietta, Georgia 30060
Contact:
Laura Murphy
470-793-4046
Laura.Murphy@wellstar.org

Hamilton Mill Clinical Research
Dacula, Georgia 30019
Contact:
Charles Schonhar
470-297-6789
dschonhar@vitalinkresearch.com

University of Alabama at Birmingham
Birmingham, Alabama 35294
Contact:
Michele N Blue, RN
205-975-4336
mblue@uabmc.edu

More Details

NCT ID
NCT02630316
Status
Recruiting
Sponsor
United Therapeutics

Study Contact

Kristan Rollins
krollins@unither.com