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Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis

NCT05255991 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 597

Last updated 2025-08-15

No results posted yet for this study

Summary

Study RIN-PF-303 is a multinational study designed to evaluate the superiority of inhaled treprostinil against placebo for the change in absolute forced vital capacity (FVC) from baseline to Week 52.

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
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-04
Primary Completion
2025-06-30
Completion
2025-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • Argentina
  • Australia
  • Belgium
  • Chile
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Mexico
  • Netherlands
  • New Zealand
  • Peru
  • South Korea
  • Spain
  • Taiwan

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 NCT05255991 on ClinicalTrials.gov