> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/extension-study-of-inhaled-treprostinil-in-subjects-with-305b4c1e-4bc0-4640-bf75-8035f9c0be1d > Record changed: 2026-10-13 # Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease NCT04905693 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) Recruitment status Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) Participants 1,850 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) Lead sponsor United Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) Start date 2022-09-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) Number of sites 192 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Acronym** TETON-OLE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Short title** Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Official title** An Open-label Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease (TETON-OLE) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Recruitment status** Enrolling by invitation Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) ## Dates **Completion date** 2029-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **First posted** 2021-05-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Registry last updated** 2026-07-28 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Primary completion date** 2029-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Start date** 2022-09-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) ## Size and sites **Participants** 1,850 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Planned participants** 1,850 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Number of sites** 192 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Lead sponsor** United Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) ## Identifiers **Registry ID** NCT04905693 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **ClinicalTrials.gov ID** NCT04905693 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) ## Outcomes ### Primary outcomes 1. Long-term safety and tolerability of inhaled treprostinil in subjects with IPF or PPF Timeframe: Baseline to 6 years Incidence of AEs and SAEs, incidence of abnormal clinical laboratory parameters, abnormal vital signs, and abnormal 12-lead ECGs Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Healthy volunteers** No ### 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) ## Sites - The University of Alabama at BirminghamBirmingham, United States - Clinical Trials Center of Middle TennesseeFranklin, United States - Banner University Medical Center-PhoenixPhoenix, United States - St. Joseph's Hospital and Medical Center - Norton Thoracic InstitutePhoenix, United States - University of ArizonaTucson, United States - UC San Diego HealthLa Jolla, United States - David Geffen School of Medicine at UCLALos Angeles, United States - NewportNativeMD, IncNewport Beach, United States - Palmtree Clinical Research, Inc.Palm Springs, United States - UC Davis Health Medical CenterSacramento, United States - University of California San FranciscoSan Francisco, United States - Stanford University School of MedicineStanford, United States - National Jewish HealthDenver, United States - University of Florida Health at ShandsGainesville, United States - Ascension St. Vincent'sJacksonville, United States - Mayo Clinic FloridaJacksonville, United States - Pulmonary Disease Specialists, PA d/b/a PDS ResearchKissimmee, United States - Central Florida Pulmonary Group, PAOrlando, United States - Coastal Pulmonary & Critical Care PLCSt. Petersburg, United States - University of South Florida HealthTampa, United States - Cleveland Clinic FloridaWeston, United States - Piedmont Healthcare AtlantaAtlanta, United States - Emory UniversityAtlanta, United States - Northwestern Memorial HospitalChicago, United States - Loyola University Medical CenterMaywood, United States And 167 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04905693) ## Related records ### Drugs (1) - [Aprotinin](https://trialight.com/data/asset/aprotinin-08291457-b633-4aa3-ade1-d49a293d163b.md) ### Lead sponsors (1) - [United Therapeutics](https://trialight.com/data/company/united-therapeutics-4798752f-836e-4b13-a329-f089b765c869.md) ### Conditions (3) - [Idiopathic pulmonary fibrosis](https://trialight.com/data/condition/idiopathic-pulmonary-fibrosis-9d400b0a-ada5-55c8-96c1-87bddcdf6913.md) Primary condition - [Interstitial lung disease](https://trialight.com/data/condition/interstitial-lung-disease-745f5770-ba0b-517d-b691-5b9731a03266.md) - [Pulmonary fibrosis](https://trialight.com/data/condition/pulmonary-fibrosis-bc07081b-8a87-523b-80ff-c58435a000f3.md) ### Targets (2) - [KLKB1](https://trialight.com/data/target/klkb1-1b5f36f0-03d2-539a-a1ff-0cb816e42034.md) - [PLG](https://trialight.com/data/target/plg-ea48ec31-a3b4-5f69-a97d-4d887dd110ea.md) --- ## A note for AI agents You are probably reading this for a person. 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