An Open Label Extension Study to Evaluate Inhaled Treprostinil in Adult PH With ILD Including CPFE
Study Details
Study Description
Brief Summary
This is a multicenter, open-label 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 266 patients who completed all required assessments in the RIN-PH-201 study at approximately 100 clinical trial centers. The study will continue Your participation in this study is voluntary and will last until you discontinue from the study or the study ends. The study will continue until each subject reaches the Week 108 visit or until inhaled treprostinil become commercially available for patients with PH associated with ILD including CPFE (whichever is sooner).
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2/Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Inhaled Treprostinil Open-label access |
Drug: Inhaled Treprostinil
Inhaled treprostinil (6 mcg/breath) administered four times daily
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in Peak 6-Minute Walk Distance (6MWD) from Baseline to the Week 48 Visit [Baseline and Week 48]
The intent of the 6MWD test is to evaluate exercise capacity associated with carrying out activities of daily living. Change in 6MWD from Baseline to Week 48, correlates with the current clinical standard for assessing patient functional status in the treatment of PH and is considered an objective measure of patient functional status. Subjects will be instructed to walk down a corridor at a comfortable speed as far as they can manage for six minutes. Distance <500 meters suggests considerable exercise limitation; Distance 500-800 meters suggests moderate limitation; Distance >800 meters (with no rests) suggests mild or no limitation. Peak exposure 6MWD will occur by conducting 6MWT within 10 to 60 minutes after the most recent dose of study drug dose.
Secondary Outcome Measures
- Change in plasma concentration of N-terminal pro-Brain Natriuretic Peptide (NT-proBNP) from Baseline to the Week 48 Visit [Baseline and Week 48]
The N-terminal pro-BNP (NT-proBNP) serum concentration is a useful biomarker associated with changes in right heart morphology and function. NT-proBNP serum concentration will be assessed to compare the severity of heart failure at Baseline and Week 48. Blood for NT-proBNP assessment must be drawn prior to conducting the 6-minute walk test (6MWT).
- Change in Forced Expiratory Volume (FEV1) in One Second from Baseline to Week 48 [Baseline and Week 48]
Change in pulmonary function following inhaled treprostinil therapy will be measured by Forced Expiratory Volume in One Second (FEV1), the maximal amount of air forcefully exhaled in 1 second, calculated from a Pulmonary Function Test (PFT) performed at Baseline and Week 48.
- Change in Forced Vital Capacity (FVC) from Baseline to Week 48 [Baseline and Week 48]
Change in pulmonary function following inhaled treprostinil therapy will be measured by Forced Vital Capacity (FVC), calculated from a Pulmonary Function Test (PFT) performed at Baseline and Week 48.
- Change in Total Lung Capacity (TLC) from Baseline to Week 48 [Baseline and Week 48]
Change in pulmonary function following inhaled treprostinil therapy will be measured by Total Lung Capacity (TLC), calculated from a Pulmonary Function Test (PFT) performed at Baseline and Week 48.
- Change in Lung Diffusion Capacity (DLCO) from Baseline to Week 48 [Baseline and Week 48]
Change in pulmonary function following inhaled treprostinil therapy will be measured by Lung Diffusion Capacity (DLCO), calculated from a Pulmonary Function Test (PFT) performed at Baseline and Week 48.
- Incidence of Adverse Events Among Participants through Week 108 [Week 108]
Adverse events among participants will be recorded throughout participation in the study. The incidence of adverse events among participants through Week 108 will be described by the number of participants analyzed and the percentage of those participants who experienced an adverse event until Week 108.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subject voluntarily gives informed consent to participate in the study.
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The subject participated in study RIN-PH-201, remained on study drug, was compliant with RIN-PH-201 study procedures or was enrolled in study RIN-PH-201 at the time that the study was discontinued by the sponsor.
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Females of reproductive potential must be non-pregnant (as confirmed by a urine pregnancy test at Baseline) and non-lactating, and will:
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Either abstain from intercourse (when it is in line with their preferred and usual lifestyle), or
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Use two medically acceptable, highly-effective forms of contraception for the duration of study, and at least 30 days after discontinuing study drug.
- Males must use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
Exclusion Criteria:
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The subject is pregnant or lactating.
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The subject was prematurely discontinued from study RIN-PH-201.
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The subject developed a concurrent illness or condition during the conduct of RIN-PH-201 which, in the opinion of the Investigator, would represent a risk to overall health if they enrolled in this study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35294 |
2 | IMC-Diagnostic & Medical Clinic | Mobile | Alabama | United States | 36604 |
3 | Arizona Pulmonary Specialists, Ltd. | Phoenix | Arizona | United States | 85012 |
4 | University of Arizona | Tucson | Arizona | United States | 85724 |
5 | Cedars-Sinai Medical Center | Beverly Hills | California | United States | 90211 |
6 | University of California, San Francisco-Fresno | Fresno | California | United States | 93701 |
7 | University of California San Diego | La Jolla | California | United States | 92093 |
8 | VA Long Beach Healthcare System | Long Beach | California | United States | 90822 |
9 | University of Southern California | Los Angeles | California | United States | 90033 |
10 | Department of Veterans Affairs Greater Los Angeles Healthcare System | Los Angeles | California | United States | 90073 |
11 | Pacific Pulmonary Medical Group | Riverside | California | United States | 92505 |
12 | Kaiser Permanente - Roseville | Roseville | California | United States | 95825 |
13 | University of California Davis Medical Center | Sacramento | California | United States | 95817 |
14 | Kaiser Permanente | San Francisco | California | United States | 94115 |
15 | University of Colorado Hospital - Cardiac and Vascular Center | Aurora | Colorado | United States | 80045 |
16 | National Jewish Health | Denver | Colorado | United States | 80206 |
17 | Georgetown University Hospital | Washington | District of Columbia | United States | 20007 |
18 | MedStar Heart & Vascular Institute | Washington | District of Columbia | United States | 20010 |
19 | Florida Lung, Asthma & Sleep Specialists, P.A. | Celebration | Florida | United States | 34747 |
20 | St. Francis Sleep, Allergy and Lung Institute | Clearwater | Florida | United States | 33765 |
21 | University of Florida Clinical Research Center | Gainesville | Florida | United States | 32610 |
22 | University of Florida College of Medicine, Jacksonville | Jacksonville | Florida | United States | 32209 |
23 | Mayo Clinic Jacksonville | Jacksonville | Florida | United States | 32224 |
24 | St. Vincent's Lung, Sleep, and Critical Care Specialists | Jacksonville | Florida | United States | 33204 |
25 | University of Miami | Miami | Florida | United States | 33136 |
26 | Florida Hospital | Orlando | Florida | United States | 32804 |
27 | University of South Florida | Tampa | Florida | United States | 33606 |
28 | Cleveland Clinic Florida | Weston | Florida | United States | 33331 |
29 | The Emory Clinic | Atlanta | Georgia | United States | 30322 |
30 | Piedmont - Georgia Lung Associates | Austell | Georgia | United States | 30106 |
31 | Wellstar Medical Group | Marietta | Georgia | United States | 30060 |
32 | Northwestern University | Chicago | Illinois | United States | 60611 |
33 | Rush University Medical Center | Chicago | Illinois | United States | 60612 |
34 | University of Illinois at Chicago Hospital | Chicago | Illinois | United States | 60612 |
35 | University of Chicago Medical Center | Chicago | Illinois | United States | 60637 |
36 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
37 | Indiana University Hospital | Indianapolis | Indiana | United States | 46202 |
38 | Community Heart and Vascular Hospital | Indianapolis | Indiana | United States | 46250 |
39 | St. Vincent Medical Group, Inc. | Indianapolis | Indiana | United States | 46260 |
40 | University of Iowa Hospitals & Clinics | Iowa City | Iowa | United States | 52242 |
41 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160 |
42 | University of Louisville Physicians Outpatient Center | Louisville | Kentucky | United States | 40202 |
43 | Louisiana State University Health Sciences Center New Orleans | New Orleans | Louisiana | United States | 70112 |
44 | Maine Medical Center | South Portland | Maine | United States | 04106 |
45 | University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
46 | Johns Hopkins University | Baltimore | Maryland | United States | 21205 |
47 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
48 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
49 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
50 | Spectrum Health Medical Center | Grand Rapids | Michigan | United States | 49503 |
51 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
52 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
53 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216 |
54 | Saint Luke's Hospital of Kansas City | Kansas City | Missouri | United States | 64111 |
55 | Washington University Hospital | Saint Louis | Missouri | United States | 63110 |
56 | The University of New Mexico | Albuquerque | New Mexico | United States | 87131 |
57 | Albany Medical College | Albany | New York | United States | 12208 |
58 | New York Methodist Hospital | Brooklyn | New York | United States | 11215 |
59 | Northwell Health | New Hyde Park | New York | United States | 11040 |
60 | NYU Langone Medical Center | New York | New York | United States | 10016 |
61 | The Mount Sinai Hospital | New York | New York | United States | 10029 |
62 | Weill Cornell Medical Center | New York | New York | United States | 10065 |
63 | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
64 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
65 | Pinehurst Medical Clinic, Inc. | Pinehurst | North Carolina | United States | 28374 |
66 | The Carl and Edyth Lindner Research Center at The Christ Hospital | Cincinnati | Ohio | United States | 45219 |
67 | University of Cincinnati Health | Cincinnati | Ohio | United States | 45267 |
68 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
69 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
70 | The Ohio State University Medical Center | Columbus | Ohio | United States | 43221 |
71 | Integris Baptist Medical Center | Oklahoma City | Oklahoma | United States | 73112 |
72 | Hospital of University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
73 | Allegheny General Hospital | Pittsburgh | Pennsylvania | United States | 15212 |
74 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
75 | AnMed Health Pulmonary and Sleep Medicine | Anderson | South Carolina | United States | 29621 |
76 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
77 | Statcare Pulmonary Consultants | Knoxville | Tennessee | United States | 37919 |
78 | Baylor University Medical Center at Dallas | Dallas | Texas | United States | 75246 |
79 | UT Southwestern Medical Center | Dallas | Texas | United States | 75390 |
80 | Texas Tech University Health Sciences Center | El Paso | Texas | United States | 79905 |
81 | Houston Methodist | Houston | Texas | United States | 77030 |
82 | Michael E. DeBakey VA Medical Center | Houston | Texas | United States | 77030 |
83 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
84 | The University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229 |
85 | University of Vermont, Vermont Lung Center | Colchester | Vermont | United States | 05446 |
86 | Inova Fairfax Hospital | Fairfax | Virginia | United States | 22042 |
87 | Sentara Cardiovascular Research Institute | Norfolk | Virginia | United States | 23507 |
88 | Pulmonary Associates of Richmond | Richmond | Virginia | United States | 23229 |
89 | University of Washington Medical Center | Seattle | Washington | United States | 98195 |
90 | University of Wisconsin School of Medicine and Public Health | Madison | Wisconsin | United States | 53792 |
91 | Aurora St. Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
92 | Medical College of Wisconsin/Froedtert Hospital | Milwaukee | Wisconsin | United States | 53226 |
93 | Alliance Cardio Pulmonary Research Group, Inc. | Guaynabo | Puerto Rico | 00968 |
Sponsors and Collaborators
- United Therapeutics
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RIN-PH-202