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NCT05943535 · ClinicalTrials.gov registry record · Phase 3
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
A Phase 3 study of Interstitial Lung Disease and Progressive Pulmonary Fibrosis, sponsored by United Therapeutics.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 698
- Enrollment target
- 20
- Study locations
NCT05943535: Recruiting Phase 3 study of Interstitial Lung Disease and Progressive Pulmonary Fibrosis, sponsored by United Therapeutics.
NCT05943535 is a Phase 3 study of Interstitial Lung Disease and Progressive Pulmonary Fibrosis that is actively recruiting participants, run by United Therapeutics. The registered enrollment target is 698 participants, above the 547-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05943535, a Phase 3 study of Interstitial Lung Disease and Progressive Pulmonary Fibrosis, is actively recruiting participants, sponsored by United Therapeutics.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 698 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The FVC measurement indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Inhaled Treprostinil
- DEVICE Treprostinil Ultrasonic Nebulizer
Study Locations (20)
California
- Peter Morton Medical Building - Los Angeles
- NewportNativeMD, Inc. - Newport Beach
- University of California Irvine Medical Center - Orange
- Paradigm Clinical Research - Redding
- UC Davis Health Medical Center - Sacramento
- Paradigm Clinical Research - San Diego
- Stanford University Medical Center - Stanford
Illinois
- Northwestern Memorial Hospital, Clinical Research Unit - Chicago
- Rush University Medical Center Outpatient Pulmonary Clinic - Chicago
- UI Health Hospital - Chicago
- Loyola University Medical Center - Maywood
Florida
- Ascension Medical Group St. Vincent's Lung Institute - Jacksonville
- Mayo Clinic - Jacksonville
- TGH/USF Center for Advanced Lung Disease and Lung Transplant - Tampa
Arizona
- Banner University Medical Center Phoenix Lung Institute - Phoenix
- Norton Thoracic Institute - Phoenix
Alabama
- UAB Lung Health Center - Birmingham
District of Columbia
- Georgetown University Hospital - Washington D.C.
Georgia
- The Emory Clinic - Atlanta
Kansas
- University of Kansas Medical Center - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 698 participants |
| Start Date | 2023-10-30 |
| Est. Completion | 2027-11 |
| Phase | Phase 3 |
What NCT05943535 shows while recruiting
NCT05943535 is an interventional study that assigns participants to a tested intervention. The registered 698 participants enrollment target is mid-sized for trials with a published cap, above the 547-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (28% higher).
The record links to 2 conditions, with Interstitial Lung Disease appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT05943535 names 20 study sites across 8 states, led by California, Illinois, Florida.
Frequently Asked Questions
What is clinical trial NCT05943535 about?
NCT05943535 is a clinical study titled "Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)". 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.
What is the current status of trial NCT05943535?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 698 participants. The study started on 2023-10-30. Estimated completion is 2027-11.
What conditions does trial NCT05943535 study?
This clinical trial studies the following conditions: Interstitial Lung Disease, Progressive Pulmonary Fibrosis.
What interventions are being tested in trial NCT05943535?
The interventions under investigation include: Placebo (DRUG), Inhaled Treprostinil (DRUG), Treprostinil Ultrasonic Nebulizer (DEVICE).
Who is sponsoring clinical trial NCT05943535?
This trial is sponsored by United Therapeutics, which has 63 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05943535 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05943535's enrollment target sits among peer trials
698 6th of 36 higher than 31 of 36 other Interstitial Lung Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Interstitial Lung Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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