Trial · NCT05943535
Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
NCT05943535, Phase 3, Recruiting, United Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF). Trials, record NCT05943535. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05943535
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Progressive Pulmonary Fibrosis (TETON-PPF)
- NCT number
- NCT05943535
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 698 participants, estimated
- Lead sponsor
- United Therapeutics
- Conditions
- Progressive Pulmonary Fibrosis, Interstitial Lung Disease
- Interventions
- Placebo, Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer
- First posted
- 2023-07-13
- Last updated
- 2026-07-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Absolute FVC from Baseline to Week 52 | Baseline to Week 52 | The FVC measurement indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath. |
| Secondary | Time to First Clinical Worsening | Baseline to Week 52 | Clinical worsening is monitored from randomization until 1 of the following criteria are met: death (all causes), hospitalization due to a respiratory indication, or ≥10% relative decline in % predicted FVC. |
| Secondary | Time to First Acute Exacerbation of ILD | Baseline to Week 52 | An exacerbation of ILD is defined as an acute, clinically significant, respiratory deterioration characterized by evidence of new widespread alveolar abnormality. |
| Secondary | Overall Survival at Week 52 | Week 52 | Vital status will be assessed for all subjects at Week 52, including those who discontinue the study prematurely or who withdraw consent. |
| Secondary | Change in % Predicted FVC from Baseline to Week 52 | Baseline to Week 52 | The FVC measurement indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath. Percent predicted FVC is calculated based on factors such as race, sex, age, height, and weight. |
| Secondary | Change in K-BILD Questionnaire Score from Baseline to Week 52 | Baseline to Week 52 | The K-BILD is a self-administered, 15-item questionnaire validated for patients with ILD consisting of 3 domains (breathlessness and activities, psychological, and chest symptoms). |
| Secondary | Change in DLCO from Baseline to Week 52 | Baseline to Week 52 | The DLCO measurement measures how well oxygen moves from the lungs to the blood. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42548323 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05943535
GET https://conductscience.org/api/trials/v1/NCT05943535/registered