Evidence map›Paper›PMID 29409488›Full record

Trial reportRespiratory research2018

The topical study of inhaled drug (salbutamol) delivery in idiopathic pulmonary fibrosis.

Omar S Usmani, Martyn F Biddiscombe, Shuying Yang, Sally Meah, Eunice Oballa, Juliet K Simpson, William A Fahy, Richard P Marshall, Pauline T Lukey, Toby M Maher

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

Trial report in Respiratory research, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01457261 (A Study of the Pharmacokinetics and Deposition of Inhaled Salbutamol in Patients With Idiopathic Pulmonary Fibrosis), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.9field-weighted citation impact, top 9% 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.

NCT01457261 phase1completednot on this map

A Study of the Pharmacokinetics and Deposition of Inhaled Salbutamol in Patients With Idiopathic Pulmonary Fibrosis (TOPICAL-IPF)

TypeinterventionalSponsorRoyal Brompton & Harefield NHS Foundation TrustRan2012 to 2014Enrolled10ConditionsIdiopathic Pulmonary FibrosisArmsSalbutamol
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 32 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. Review
  5. Review
  6. Observational
  7. Emerging drug delivery strategies for idiopathic pulmonary fibrosis treatment.European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V · 2021
    Review
  8. Review
  9. Article
  10. Feasibility of Aerosolized Alpha-1 Antitrypsin as a Therapeutic Option.Chronic obstructive pulmonary diseases (Miami, Fla.) · 2020
    Review
  11. Article
  12. Article
  13. Article
  14. Inhaled Biologicals for the Treatment of Cystic Fibrosis.Recent patents on inflammation & allergy drug discovery · 2019
    Review
  15. Review
  16. Review
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 2 institutions in 2 countries.

Omar S UsmaniAirways Disease Section, National Heart and Lung Institute, Imperial College London and Royal Brompton Hospital, London, UK.
Martyn F BiddiscombeAirways Disease Section, National Heart and Lung Institute, Imperial College London and Royal Brompton Hospital, London, UK.
Shuying YangGlaxoSmithKline R&D, Clinical Pharmacology, Modelling and Simulation, Stockley Park, London, UK.
Sally MeahAirways Disease Section, National Heart and Lung Institute, Imperial College London and Royal Brompton Hospital, London, UK.
Eunice OballaGlaxoSmithKline R&D, Fibrosis and Lung Injury Discovery Performance Unit, Stevenage, UK.
Juliet K SimpsonGlaxoSmithKline R&D, Fibrosis and Lung Injury Discovery Performance Unit, Stevenage, UK.
William A FahyGlaxoSmithKline R&D, Respiratory Discovery Medicine, Stockley Park, London, UK.
Richard P MarshallGlaxoSmithKline R&D, Fibrosis and Lung Injury Discovery Performance Unit, Stevenage, UK.
Pauline T LukeyGlaxoSmithKline R&D, Fibrosis and Lung Injury Discovery Performance Unit, Stevenage, UK.
Toby M MaherNIHR Respiratory Biomedical Research Unit, Royal Brompton Hospital, London, UK. t.maher@rbht.nhs.uk.ORCID 0000-0001-7192-9149
GlaxoSmithKline (United Kingdom) · GBRoyal Brompton Hospital · GB

Funding

GlaxoSmithKline COL29296HSRD VA CDA 13-017
6 · The paper itself

Abstract

backgroundOur aim was to investigate total and regional lung delivery of salbutamol in subjects with idiopathic pulmonary fibrosis (IPF).

methodsThe TOPICAL study was a 4-period, partially-randomised, controlled, crossover study to investigate four aerosolised approaches in IPF subjects. Nine subjects were randomised to receive

resultsSmall monodisperse particles (1.5 μm) achieved significantly better total lung deposition (TLD, mean % ± SD) than larger particles (6 μm), where polydisperse nebulisation was poor; (TLD, 64.93 ± 10.72; 50.46 ± 17.04; 8.19 ± 7.72, respectively). Small monodisperse particles (1.5 μm) achieved significantly better lung penetration (mean % ± SD) than larger particles (6 μm), and polydisperse nebulisation showed lung penetration similar to the small particles; PI (mean ± SD) 0.8 ± 0.16, 0.49 ± 0.21, and 0.73 ± 0.19, respectively. Higher dose-normalised plasma salbutamol levels were observed following monodisperse 1.5 μm and 6 μm particles, compared to polydisperse pMDI inhalation, while lowest plasma levels were observed following polydisperse nebulisation.

conclusionOur data is the first systematic investigation of inhaled drug delivery in fibrotic lung disease. We provide evidence that inhaled drugs can be optimised to reach the peripheral areas of the lung where active scarring occurs in IPF.

trial registrationThis trial was registered on clinicaltrials.gov ( NCT01457261 ).

Indexed as

Administration, InhalationAdministration, TopicalAgedAged, 80 and overAlbuterolBronchodilator AgentsCross-Over StudiesDose-Response Relationship, DrugDrug Delivery SystemsFemaleHumansIdiopathic Pulmonary FibrosisMaleMiddle AgedAlbuterolBronchodilator AgentsGamma scintigraphyIdiopathic pulmonary fibrosis (IPF)Inhaled drug delivery

Identifiers

PMID29409488
PMCPMC5801831
OpenAlexW2801796918

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.