MedTrace Logo

Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)

NCT05943535 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 698

Last updated 2026-05-07

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Placebo

Placebo administered QID

DRUG

Inhaled Treprostinil

Inhaled treprostinil (6 mcg/breath) administered QID

DEVICE

Treprostinil Ultrasonic Nebulizer

Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.

Sponsors & Collaborators

  • United Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2027-11-30
Completion
2027-11-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Canada
  • Chile
  • France
  • Germany
  • Israel
  • Italy
  • New Zealand
  • Peru
  • South Korea
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05943535 on ClinicalTrials.gov