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Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease

Enrolling By InvitationPhase 3

Sponsor: United Therapeutics

Conditions: Idiopathic Pulmonary Fibrosis, Interstitial Lung Disease, Progressive Pulmonary Fibrosis

Interventions: Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer

Countries: United States, Argentina, Australia, Belgium, Canada, Chile, Denmark, France

Study RIN-PF-302 is designed to evaluate the long-term safety and tolerability of inhaled treprostinil in subjects with idiopathic pulmonary fibrosis or progressive pulmonary fibrosis.

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Subject gives voluntary informed consent to participate in the study.
2. The subject participated in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 and remained on study drug and completed all scheduled study visits or was enrolled in Study RIN-PF-301, Study RIN-PF-303, or Study RIN-PF-305 at the time that the study or study subject was discontinued by the Sponsor for reasons other than safety.
3. Women of childbearing potential must be non-pregnant (as confirmed by a urine pregnancy test at OLE Entry Visit) and non-lactating, and will agree to abstain from intercourse (when it is in line with their preferred and usual lifestyle) or use 2 medically acceptable, highly effective forms of contraception for the duration of the study, and at least 30 days after discontinuing study drug.
4. Males with a partner of childbearing potential must agree to use a condom for the duration of treatment and for at least 48 hours after discontinuing study drug.
5. 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.

Exclusion Criteria:

1. Subject is pregnant or lactating.
2. In the opinion of the Investigator, enrollment in Study RIN-PF-302 would represent a risk to the subject's overall health.
3. Use of any other investigational drug/device or participation in any investigational study in which the subject received a medical intervention (ie, procedure, device, medication/supplement). Subjects participating in non-interventional, observational, or registry studies are eligible.

Locations (192)

Birmingham, Alabama, United States
Franklin, Arizona, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
La Jolla, California, United States
Los Angeles, California, United States
Newport Beach, California, United States
Palm Springs, California, United States
Sacramento, California, United States
San Francisco, California, United States
Stanford, California, United States
Denver, Colorado, United States
Gainesville, Florida, United States
Jacksonville, Florida, United States
Jacksonville, Florida, United States
Kissimmee, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Weston, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Louisville, Kentucky, United States
New Orleans, Louisiana, United States
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