Evidence map›Paper›PMID 35787522›Full record

ArticleBMJ open respiratory research2022

Study design and rationale for the TETON phase 3, randomised, controlled clinical trials of inhaled treprostinil in the treatment of idiopathic pulmonary fibrosis.

Steven D Nathan, Jurgen Behr, Vincent Cottin, Lisa Lancaster, Peter Smith, C Q Deng, Natalie Pearce, Heidi Bell, Leigh Peterson, Kevin R Flaherty

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open respiratory research, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 39 papers.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed
8.8field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04708782 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-1)

TypeinterventionalSponsorUnited TherapeuticsRan2021 to 2026Enrolled598ConditionsIdiopathic Pulmonary Fibrosis, Interstitial Lung DiseaseArmsPlacebo, Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer
NCT05255991 phase3completednot on this map

A Randomized, Double-blind, Placebo-controlled, Multinational, Phase 3 Study of the Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis (TETON-2)

TypeinterventionalSponsorUnited TherapeuticsRan2022 to 2025Enrolled597ConditionsIdiopathic Pulmonary Fibrosis, Interstitial Lung DiseaseArmsPlacebo, Inhaled Treprostinil, Treprostinil Ultrasonic Nebulizer
3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 64 citations in OpenAlex.

  1. Trial
  2. Multi-omics insights into the mechanisms and prognosis of IPF.Genes and environment : the official journal of the Japanese Environmental Mutagen Society · 2026
    Review
  3. Article
  4. Review
  5. Review
  6. Article
  7. Review
  8. Mechanobiology and Resolution of Lung Fibrosis.Annual review of physiology · 2026
    Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Article
  14. Review
  15. Review
  16. Emerging Concepts in Therapeutic Interventions for Idiopathic Pulmonary Fibrosis.Seminars in respiratory and critical care medicine · 2025
    Review
  17. Review
  18. Article
  19. Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 3 countries.

Steven D NathanLung Transplant Program, Inova Fairfax Hospital, Falls Church, Virginia, USA steven.nathan@inova.org.
Jurgen BehrDepartment of Medicine V, University Hospital, Ludwig Maximilians University Munich, Comprehensive Pneumology Center, Member of the German Center for Lung Research (DZL), Munich, Germany.
Vincent CottinService de pneumologie, Hospices Civils de Lyon, Hôpital Louis Pradel, National des maladies pulmonaires ra, Lyon, France.
Lisa LancasterDivision of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Peter SmithProduct Development, United Therapeutics Corp Research and Development, Research Triangle Park, North Carolina, USA.
C Q DengProduct Development, United Therapeutics Corp Research and Development, Research Triangle Park, North Carolina, USA.
Natalie PearceProduct Development, United Therapeutics Corp Research and Development, Research Triangle Park, North Carolina, USA.ORCID 0000-0002-0545-6432
Heidi BellProduct Development, United Therapeutics Corp Research and Development, Research Triangle Park, North Carolina, USA.
Leigh PetersonProduct Development, United Therapeutics Corp Research and Development, Research Triangle Park, North Carolina, USA.
Kevin R FlahertyDivision of Pulmonary and Critical Care Medicine, University of Michigan Hospital, Ann Arbor, Michigan, USA.
United Therapeutics (United States) · USGerman Center for Lung Research · DEHospices Civils de Lyon · FRInova Fairfax Hospital · USUniversity of Michigan · USVanderbilt University Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIdiopathic pulmonary fibrosis (IPF) greatly impacts quality of life and eventually leads to premature death from respiratory failure. Inhaled treprostinil was associated with improvements in forced vital capacity (FVC) and reduced exacerbations of underlying lung disease in post hoc analyses from a phase 3 study in patients with precapillary pulmonary hypertension due to interstitial lung disease. These results, combined with preclinical evidence of treprostinil's antifibrotic activity, support its investigation in the treatment of IPF. METHODS AND ANALYSIS: The TETON programme consists of two replicate, 52-week, randomised, double-blind placebo-controlled, phase 3 studies, each enrolling 396 subjects (NCT04708782, NCT05255991). Eligible subjects must have a diagnosis of IPF confirmed by central imaging review, along with an FVC ≥45%. Stable background use of pirfenidone or nintedanib is allowed. The primary endpoint is change in absolute FVC at week 52. Secondary endpoints include time to clinical worsening (first event of death, respiratory hospitalisation or ≥10% decline in % predicted FVC), time to first acute exacerbation of IPF, overall survival, change in % predicted FVC and change in the King's Brief Interstitial Lung Disease Questionnaire at week 52. Safety parameters include adverse events, hospitalisations, oxygenation and laboratory parameters. Patients who complete week 52 will be eligible to enter an open-label extension study. ETHICS AND DISSEMINATION: Studies will be conducted in accordance with the International Conference on Harmonisation Guideline for Good Clinical Practice, Declaration of Helsinki principles, and local regulatory, ethical and legal requirements. Results will be published in a peer-reviewed publication.

Indexed as

Idiopathic Pulmonary FibrosisDouble-Blind MethodEpoprostenolHumansQuality of LifeRandomized Controlled Trials as TopicTreatment OutcomeEpoprostenoltreprostinilInterstitial FibrosisNebuliser therapyRare lung diseases

Identifiers

PMID35787522
PMCPMC9255390
OpenAlexW4283810334

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.