Evidence map›Paper›PMID 30578394›Full record

Trial reportThe European respiratory journal2019

Phase 2 clinical trial of PBI-4050 in patients with idiopathic pulmonary fibrosis.

Nasreen Khalil, Helene Manganas, Christopher J Ryerson, Shane Shapera, Andre M Cantin, Paul Hernandez, Eric E Turcotte, Joseph M Parker, John E Moran, Gary R Albert and 6 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in The European respiratory journal, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 52 papers.

0numbers the graph read from it
0cells of the map it votes in
52citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

52 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Review
  7. The importance of mechanical forces in chronic respiratory diseases.European respiratory review : an official journal of the European Respiratory Society · 2026
    Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Pulmonary fibrosis: from mechanisms to therapies.Journal of translational medicine · 2025
    Review
  13. Article
  14. Article
  15. Immunobiology of pulmonary fibrosis.Frontiers in immunology · 2025
    Review
  16. Review
  17. Review
  18. Understanding myofibroblast origin in the fibrotic lung.Chinese medical journal pulmonary and critical care medicine · 2024
    Review
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors.

Nasreen KhalilVancouver General Hospital - The Lung Centre, Vancouver, BC, Canada.
Helene ManganasCentre Hospitalier de l'Université de Montréal, Montréal, QC, Canada.
Christopher J RyersonDept of Medicine, University of British Columbia and Centre for Heart Lung Innovation, St. Paul's Hospital, Vancouver, BC, Canada.
Shane ShaperaUniversity Health Network, University of Toronto, Toronto, ON, Canada.
Andre M CantinCentre de Recherche Clinique du Centre Hospitalier Universitaire de Sherbrooke (CHUS-CRC), Sherbrooke, QC, Canada.
Paul HernandezQueen Elizabeth II Health Sciences Centre, Halifax, NS, Canada.
Eric E TurcotteCentre d'Imagerie Moléculaire de Sherbrooke, Université de Sherbrooke, Sherbrooke, QC, Canada.
Joseph M ParkerPrometic Life Sciences Inc., Laval, QC, Canada.
John E MoranPrometic Life Sciences Inc., Laval, QC, Canada.
Gary R AlbertPrometic Life Sciences Inc., Laval, QC, Canada.
Renata SawtellPrometic Life Sciences Inc., Laval, QC, Canada.
Aline HagerimanaPrometic Life Sciences Inc., Laval, QC, Canada.
Pierre LaurinPrometic Life Sciences Inc., Laval, QC, Canada.
Lyne GagnonPrometic Life Sciences Inc., Laval, QC, Canada.
Frank CesariPrometic Life Sciences Inc., Laval, QC, Canada.
Martin KolbFirestone Institute for Respiratory Health, St. Joseph's Healthcare, Hamilton, ON, Canada kolbm@mcmaster.ca.ORCID 0000-0003-3837-1467

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

PBI-4050 is a novel orally active small-molecule compound with demonstrated anti-fibrotic activity in several models of fibrosis, including lung fibrosis. We present results from our first clinical study of PBI-4050 in patients with idiopathic pulmonary fibrosis (IPF).This 12-week open-label study explored the safety, efficacy and pharmacokinetics of daily oral doses of 800 mg PBI-4050 alone and in combination with nintedanib or pirfenidone in patients with predominantly mild or moderate IPF. Nine patients received PBI-4050 alone, 16 patients received PBI-4050 with nintedanib and 16 patients received PBI-4050 with pirfenidone.PBI-4050 alone or in combination with nintedanib or pirfenidone was well tolerated. Pharmacokinetic profiles for PBI-4050 were similar in the PBI-4050 alone and PBI-4050+nintedanib groups but reduced in the PBI-4050+pirfenidone group, suggesting a drug-drug interaction. There were no significant changes in forced vital capacity (FVC), either in % predicted or mL, from baseline to week 12 for PBI-4050 alone or PBI-4050+nintedanib. In contrast, a statistically significant reduction (p<0.024) in FVC % pred was seen for PBI-4050+pirfenidone after 12 weeks.There were no safety concerns with PBI-4050 alone or in combination with nintedanib or pirfenidone in IPF patients. The stability of FVC between baseline and week 12 looked encouraging for PBI-4050 alone and in combination with nintedanib.

Indexed as

AcetatesAgedAged, 80 and overDrug Therapy, CombinationFemaleHumansIdiopathic Pulmonary FibrosisIndolesMaleMiddle AgedPatient SafetyPyridonesTreatment OutcomeAcetatesIndolesnintedanibpirfenidonePyridonessetogepram

Identifiers

PMID30578394
PMCPMC6422836

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.