Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnited Therapeutics
About this trial
Study RIN-PF-305 is designed to evaluate the safety and efficacy of inhaled treprostinil in subjects with progressive pulmonary fibrosis (PPF) over a 52-week period.
Eligibility criteria
Qualifiers
Subject gives voluntary informed consent to participate in the study.
Subject is ≥18 years of age, inclusive, at the time of signing informed consent.
Subject has radiological evidence of pulmonary fibrosis of >10% extent on an HRCT scan in the previous 12 months (confirmed by central review).
Clinically significant decline in % predicted FVC based on ≥10% relative decline
Disqualifiers
Subject is pregnant or lactating.
Subject has primary obstructive airway physiology (forced expiratory volume in 1 second/FVC <0.70 at Screening) or greater extent of emphysema than fibrosis on HRCT (confirmed by central review).
Subject has a diagnosis of IPF.
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.
Trial design
Treatments tested in this trial
- Placebo
- Inhaled Treprostinil
- Treprostinil Ultrasonic Nebulizer
Treatment groups
698 Participants
are divided into 2 treatment groupsLocations
160Argentina
Instituto Ave Pulmo - Fundacion enfisema7600, Mar del PlataBuenos Aires, Argentina
Instituto Medico Rio Cuarto5800, Río CuartoCórdoba Province, Argentina
Sanatorio Parque de Rosario - Consultorios Externos2000, RosarioSanta Fe Province, Argentina
CIMER-Centro Integral de Medicina Respiratoria San Miguel de TucumánTucumán Province, Argentina
Sponsors and collaborators
United Therapeutics
Lead sponsor
Source ClinicalTrials.gov