Evidence map›Paper›PMID 35546672›Full record

Observational studyRespiratory research2022

Mass spectrometry detection of inhaled drug in distal fibrotic lung.

Theresia A Mikolasch, Eunice Oballa, Mitra Vahdati-Bolouri, Emily Jarvis, Yi Cui, Anthony Cahn, Rebecca L Terry, Jagdeep Sahota, Ricky Thakrar, Peter Marshall and 1 more

Registry-linked trialOpen access · goldAbstract readObservational Study
In one paragraph

Observational study in 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 trial NCT03136120 (Study to Assess Inhaled Drug Distribution in the Distal Lung and Interstitium Using Cryobiopsy Samples From Subjects With Suspected Interstitial Lung Disease Undergoing Cryobiopsy for Clinical Reasons), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.3field-weighted citation impact, top 43% 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.

NCT03136120 completednot on this map

Study to Assess Inhaled Drug Distribution in the Distal Lung and Interstitium Using Cryobiopsy Samples From Subjects With Suspected Interstitial Lung Disease Undergoing Cryobiopsy for Clinical Reasons

TypeobservationalSponsorGlaxoSmithKlineRan2017 to 2018Enrolled8ConditionsLung Diseases, InterstitialArmsIpratropium Bromide, Flexible Bronchoscopy/Biopsy
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 2 citations in OpenAlex.

  1. Review
  2. 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

11 authors at 2 institutions in 1 country.

Theresia A MikolaschCentre for Inflammation and Tissue Repair, UCL Respiratory, University College London, London, UK. t.mikolasch@ucl.ac.uk.ORCID http://orcid.org/0000-0002-9417-1286
Eunice OballaDiscovery Medicine, Clinical Pharmacology and Experimental Medicine, GSK Research and Development, Stevenage, UK.
Mitra Vahdati-BolouriEarly Development Leader, GSK Research, Stevenage, UK.
Emily JarvisDevelopment Biostatistics, GSK Development, Stevenage, UK.
Yi CuiSafety and Medical Governance, Pharma Safety, GSK Development, Stevenage, UK.
Anthony CahnDiscovery Medicine, Clinical Pharmacology and Experimental Medicine, GSK Research and Development, Stevenage, UK.
Rebecca L TerryPathology, In Vitro/In Vivo Translation, GSK Research, Stevenage, UK.
Jagdeep SahotaCentre for Inflammation and Tissue Repair, UCL Respiratory, University College London, London, UK.
Ricky ThakrarUniversity College London Hospitals NHS Foundation Trust, London, UK.
Peter Marshall *Bioimaging, In Vitro/In Vivo Translation, GSK Research, Stevenage, UK.
Joanna C Porter *Centre for Inflammation and Tissue Repair, UCL Respiratory, University College London, London, UK.
Age UK · GBUniversity College London Hospitals NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrently the only available therapies for fibrotic Interstitial Lung Disease are administered systemically, often causing significant side effects. Inhaled therapy could avoid these but to date there is no evidence that drug can be effectively delivered to distal, fibrosed lung. We set out to combine mass spectrometry and histopathology with rapid sample acquisition using transbronchial cryobiopsy to determine whether an inhaled drug can be delivered to fibrotic, distal lung parenchyma in participants with Interstitial Lung Disease.

methodsPatients with radiologically and multidisciplinary team confirmed fibrotic Interstitial Lung Disease were eligible for this study. Transbronchial cryobiopsies and endobronchial biopsies were taken from five participants, with Interstitial Lung Disease, within 70 min of administration of a single dose of nebulised ipratropium bromide. Thin tissue cryosections were analysed by Matrix Assisted Laser Desorption/Ionization-Mass Spectrometry imaging and correlated with histopathology. The remainder of the cryobiopsies were homogenised and analysed by Liquid Chromatography-tandem Mass Spectrometry.

resultsDrug was detected in proximal and distal lung samples from all participants. Fibrotic regions were identified in research samples of four of the five participants. Matrix Assisted Laser Desorption/Ionization-Mass Spectrometry imaging showed co-location of ipratropium with fibrotic regions in samples from three participants.

conclusionsIn this proof of concept study, using mass spectrometry, we demonstrate for the first-time that an inhaled drug can deposit in distal fibrotic lung parenchyma in patients with Interstitial Lung Disease. This suggests that drugs to treat pulmonary fibrosis could potentially be administered by the inhaled route. Trial registration A prospective clinical study approved by London Camden and Kings Cross Research Ethics Committee and registered on clinicaltrials.gov (NCT03136120).

Indexed as

Lung Diseases, InterstitialPulmonary FibrosisHumansLungMass SpectrometryProspective StudiesSpectrometry, Mass, Matrix-Assisted Laser Desorption-IonizationDrug distributionInterstitial fibrosisMALDI-MS imagingTransbronchial cryobiopsy

Identifiers

PMID35546672
PMCPMC9092847
OpenAlexW4280501697

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.