Evidence map›Paper›PMID 30765508›Full record

Trial reportThe European respiratory journal2019

A randomised, placebo-controlled study of omipalisib (PI3K/mTOR) in idiopathic pulmonary fibrosis.

Pauline T Lukey, Stephen A Harrison, Shuying Yang, Yim Man, Beverley F Holman, Alaleh Rashidnasab, Gabrielle Azzopardi, Michael Grayer, Juliet K Simpson, Philippe Bareille and 13 more

Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
PubMed Publisher
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. It is linked to trial NCT01725139 (A Randomised, Placebo-controlled, Double-blind, Repeat Dose Escalation Study With GSK2126458 in Patients With Idiopathic Pulmonary Fibrosis), which is not on this map. Cited by 88 papers.

0numbers the graph read from it
0cells of the map it votes in
88citing papers in PubMed
14.0field-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.

NCT01725139 phase1completednot on this map

A Randomised, Placebo-controlled, Double-blind, Repeat Dose Escalation Study With GSK2126458 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

TypeinterventionalSponsorGlaxoSmithKlineRan2013 to 2016Enrolled17ConditionsIdiopathic Pulmonary FibrosisArmsGSK2126458, Placebo
3 · Its place in the literature

Who cites it

88 citing papers in PubMed, 142 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Chemokine Receptor 2-targeted Molecular Imaging in Pulmonary Fibrosis. A Clinical Trial.American journal of respiratory and critical care medicine · 2021
    Trial
  4. ADAMTS14 is a novel modulator of fibroblast mechanoactivation in pulmonary fibrosis.American journal of respiratory and critical care medicine · 2026
    Article
  5. Review
  6. Review
  7. Hallmarks of the ageing lung: 10 years later.The European respiratory journal · 2026
    Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. The importance of mechanical forces in chronic respiratory diseases.European respiratory review : an official journal of the European Respiratory Society · 2026
    Review
  15. Endothelial to mesenchymal transition: a central mechanism in diabetes-induced vascular pathology.The Korean journal of physiology & pharmacology : official journal of the Korean Physiological Society and the Korean Society of Pharmacology · 2025
    Review
  16. Article
  17. Senotherapy for chronic lung disease.Pharmacological reviews · 2025
    Review
  18. Review
  19. Review
  20. Article

28 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

23 authors at 4 institutions in 1 country.

Pauline T LukeyGlaxoSmithKline Research and Development, Stevenage, UK.
Stephen A HarrisonGlaxoSmithKline Research and Development, Stevenage, UK.
Shuying YangGlaxoSmithKline Research and Development, Stevenage, UK.
Yim ManGlaxoSmithKline Research and Development, Stevenage, UK.
Beverley F HolmanUniversity College London, Institute of Nuclear Medicine, London, UK.
Alaleh RashidnasabUniversity College London, Institute of Nuclear Medicine, London, UK.
Gabrielle AzzopardiUniversity College London, Institute of Nuclear Medicine, London, UK.
Michael GrayerGlaxoSmithKline Research and Development, Stevenage, UK.
Juliet K SimpsonGlaxoSmithKline Research and Development, Stevenage, UK.
Philippe BareilleGlaxoSmithKline Research and Development, Stevenage, UK.
Lyn PaulNIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK.
Hannah V WoodcockUniversity College London, Centre for Inflammation and Tissue Repair, London, UK.
Richard ToshnerNIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK.
Peter SaundersNIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK.
Philip L MolyneauxNIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK.
Kris ThielemansUniversity College London, Institute of Nuclear Medicine, London, UK.
Frederick J WilsonGlaxoSmithKline Research and Development, Stevenage, UK.
Paul F MercerUniversity College London, Centre for Inflammation and Tissue Repair, London, UK.
Rachel C ChambersUniversity College London, Centre for Inflammation and Tissue Repair, London, UK.ORCID 0000-0003-1370-9417
Ashley M GrovesUniversity College London, Institute of Nuclear Medicine, London, UK.
William A FahyGlaxoSmithKline Research and Development, Stevenage, UK.
Richard P MarshallGlaxoSmithKline Research and Development, Stevenage, UK.
Toby M MaherNIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, London, UK t.maher@imperial.ac.uk.
GlaxoSmithKline (United Kingdom) · GBRoyal Brompton Hospital · GBUniversity College London · GBCentre for Inflammation Research · GB

Funding

Medical Research Council MR/K024078/1
6 · The paper itself

Abstract

Phosphatidylinositol 3-kinases (PI3Ks) and mammalian target of rapamycin (mTOR) play a role in the pathogenesis of idiopathic pulmonary fibrosis (IPF). Omipalisib (GSK2126458) is a potent inhibitor of PI3K/mTOR.A randomised, placebo-controlled, double-blind, repeat dose escalation, experimental medicine study of omipalisib in subjects with IPF was conducted (NCT01725139) to test safety, tolerability, pharmacokinetics and pharmacodynamics. Omipalisib was dosed at 0.25 mg, 1 mg and 2 mg twice daily for 8 days in four cohorts of four subjects randomised 3:1 to receive omipalisib or placebo (two cohorts received 2 mg twice daily).17 subjects with IPF were enrolled. The most common adverse event was diarrhoea, which was reported by four participants. Dose-related increases in insulin and glucose were observed. Pharmacokinetic analysis demonstrated that exposure in the blood predicts lung exposure. Exposure-dependent inhibition of phosphatidylinositol 3,4,5 trisphosphate and pAKT confirmed target engagement in blood and lungs.

Indexed as

Administration, OralAgedBenzenesulfonamidesDose-Response Relationship, DrugDouble-Blind MethodFemaleFluorodeoxyglucose F18HumansIdiopathic Pulmonary FibrosisLungMaleMiddle AgedPhosphatidylinositol 3-KinasesPositron Emission Tomography Computed TomographyPyridazinesQuinolinesBenzenesulfonamidesFluorodeoxyglucose F18MTOR protein, humanomipalisibPhosphatidylinositol 3-KinasesPyridazinesQuinolinesSulfonamidesTOR Serine-Threonine Kinases

Identifiers

PMID30765508
OpenAlexW2913948178

What OpenQuestion holds

Textmetadata
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.