Evidence map›Paper›PMID 32216814›Full record

Trial reportRespiratory research2020

A positron emission tomography imaging study to confirm target engagement in the lungs of patients with idiopathic pulmonary fibrosis following a single dose of a novel inhaled αvβ6 integrin inhibitor.

Toby M Maher, Juliet K Simpson, Joanna C Porter, Frederick J Wilson, Robert Chan, Rhena Eames, Yi Cui, Sarah Siederer, Simon Parry, Julia Kenny and 14 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03069989 (A Study of Single Doses to Evaluate the Safety, Tolerability, Pharmacokinetics and Target Engagement of Nebulised GSK3008348 in Idiopathic Pulmonary Fibrosis Patients, Using Positron Emission Tomography), which is not on this map. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
5.4field-weighted citation impact, top 3% 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.

NCT03069989 phase1terminatednot on this map

A Study of Single Doses to Evaluate the Safety, Tolerability, Pharmacokinetics and Target Engagement of Nebulised GSK3008348 in Idiopathic Pulmonary Fibrosis Patients, Using Positron Emission Tomography (PET) Imaging

TypeinterventionalSponsorGlaxoSmithKlineRan2017 to 2018Enrolled8ConditionsIdiopathic Pulmonary FibrosisArmsGSK3008348, Placebo, [18F]-FBA-A20FMDV2
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 79 citations in OpenAlex.

  1. Bexotegrast Shows Dose-Dependent Integrin αAnnals of the American Thoracic Society · 2025
    Trial
  2. Synthesis and preclinical development of a novelEJNMMI radiopharmacy and chemistry · 2026
    Article
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Cancer Integrin Imaging with [Molecular imaging and radionuclide therapy · 2025
    Article
  9. Pulmonary fibrosis: from mechanisms to therapies.Journal of translational medicine · 2025
    Review
  10. Article
  11. Molecular Imaging of Pulmonary Fibrosis.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2025
    Review
  12. Review
  13. Article
  14. Review
  15. Review
  16. Exploring the role of ITGB6: fibrosis, cancer, and other diseases.Apoptosis : an international journal on programmed cell death · 2024
    Review
  17. Article
  18. Review
  19. Article
  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

24 authors at 6 institutions in 1 country.

Toby M MaherRoyal Brompton Hospital, London, UK.
Juliet K SimpsonGlaxoSmithKline Research and Development, Stevenage, UK.
Joanna C PorterUniversity College London Hospital, London, UK.
Frederick J WilsonGlaxoSmithKline Research and Development, Stevenage, UK.
Robert ChanGlaxoSmithKline Research and Development, Stevenage, UK.
Rhena EamesGlaxoSmithKline Research and Development, Stevenage, UK.
Yi CuiGlaxoSmithKline Research and Development, Stevenage, UK.
Sarah SiedererGlaxoSmithKline Research and Development, Stevenage, UK.
Simon ParryGlaxoSmithKline Research and Development, Stevenage, UK.
Julia KennyGlaxoSmithKline Research and Development, Stevenage, UK.
Robert J SlackGlaxoSmithKline Research and Development, Stevenage, UK.
Jagdeep SahotaUniversity College London Hospital, London, UK.
Lyn PaulRoyal Brompton Hospital, London, UK.
Peter SaundersRoyal Brompton Hospital, London, UK.
Philip L MolyneauxRoyal Brompton Hospital, London, UK.
Pauline T LukeyGlaxoSmithKline Research and Development, Stevenage, UK.
Gaia RizzoInvicro, A Konica Minolta Company, London, UK.
Graham E SearleInvicro, A Konica Minolta Company, London, UK.
Richard P MarshallGlaxoSmithKline Research and Development, Stevenage, UK.
Azeem SaleemInvicro, A Konica Minolta Company, London, UK.
Arthur R Kang'ombeGlaxoSmithKline Research and Development, Stevenage, UK.
David FairmanGlaxoSmithKline Research and Development, Stevenage, UK.
William A FahyGlaxoSmithKline Research and Development, Stevenage, UK.
Mitra Vahdati-BolouriGlaxoSmithKline Research and Development, Stevenage, UK. mitra.x.vahdati-bolouri@gsk.com.
GlaxoSmithKline (United Kingdom) · GBInvicro (United Kingdom) · GBRoyal Brompton Hospital · GBImperial College London · GBUniversity College Hospital · GBUniversity College London · GB

Funding

GlaxoSmithKline N/a
6 · The paper itself

Abstract

backgroundIdiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease with poor prognosis and a significant unmet medical need. This study evaluated the safety, pharmacokinetics (PK) and target engagement in the lungs, of GSK3008348, a novel inhaled alpha-v beta-6 (αvβ6) integrin inhibitor, in participants with IPF.

methodsThis was a phase 1b, randomised, double-blind (sponsor unblind) study, conducted in the UK (two clinical sites, one imaging unit) between June 2017 and July 2018 (NCT03069989). Participants with a definite or probable diagnosis of IPF received a single nebulised dose of 1000 mcg GSK3008348 or placebo (ratio 5:2) in two dosing periods. In period 1, safety and PK assessments were performed up to 24 h post-dose; in period 2, after a 7-day to 28-day washout, participants underwent a total of three positron emission tomography (PET) scans: baseline, Day 1 (~ 30 min post-dosing) and Day 2 (~ 24 h post-dosing), using a radiolabelled αvβ6-specific ligand, [

resultsEight participants with IPF were enrolled and seven completed the study. Adjusted posterior median reduction in uncorrected V

conclusionsThis study demonstrated engagement of the αvβ6 integrin target in the lung following nebulised dosing with GSK3008348 to participants with IPF. To the best of our knowledge this is the first time a target-specific PET radioligand has been used to assess target engagement in the lung, not least for an inhaled drug.

trial registrationclinicaltrials.gov: NCT03069989; date of registration: 3 March 2017.

Indexed as

Administration, InhalationAgedAntigens, NeoplasmBayes TheoremButyratesDouble-Blind MethodEndpoint DeterminationFemaleHumansIdiopathic Pulmonary FibrosisIntegrinsMaleNaphthyridinesNebulizers and VaporizersPositron-Emission TomographyPyrazolesAntigens, NeoplasmButyratesGSK3008348integrin alphavbeta6IntegrinsNaphthyridinesPyrazolesPyrrolidines[18F]FB-A20FMDV2, target engagementAlpha-v beta-6Idiopathic pulmonary fibrosisIntegrinIPF, positron emission tomographyPETαvβ6

Identifiers

PMID32216814
PMCPMC7099768
OpenAlexW3013324370

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.