Evidence map›Paper›PMID 34620167›Full record

ArticleRespiratory research2021

A scintigraphy study of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler in patients with moderate-to-very severe chronic obstructive pulmonary disease.

Omar Usmani, Nicolas Roche, Ezanul Wahab, Samuel Israel, Martin Jenkins, Roopa Trivedi, Paul Dorinsky, Magnus Aurivillius

2 registry-linked trialsOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Respiratory research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.5field-weighted citation impact, top 10% 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.

NCT03906045 phase1completednot on this map

A Phase I, Single-Dose, Gamma Scintigraphy Study to Assess the Pulmonary Deposition of Technetium-99m Radiolabelled Budesonide, Glycopyrronium and Formoterol Fumarate MDI in Patients With Moderate to Severe/Very Severe COPD.

TypeinterventionalSponsorAstraZenecaRan2019 to 2020Enrolled18ConditionsChronic Obstructive Pulmonary DiseaseArmsBGF-MDI
NCT06905483 phase4completednot on this mapstarted 2025, after this paper: background citation

Comparative Effects of Triple Inhaled Therapy With Budesonide/Glycopyrronium/Formoterol Versus Fluticasone Furoate/Umeclidinium/Vilanterol on Small Airway Disease in COPD Patients: A Randomized Crossover Study

TypeinterventionalSponsorThammasat UniversityRan2025 to 2026Enrolled22ConditionsCOPD, Chronic Obstructive Pulmonary Disease (COPD), Small Airway Disease, Triple TherapyArmsBudesonide/Glycopyrronium/Formoterol (BGF), Fluticasone Furoate/Umeclidinium/Vilanterol (FUV)
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 20 citations in OpenAlex.

  1. Trial
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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

8 authors at 5 institutions in 4 countries.

Omar UsmaniAsthma Lab, National Heart and Lung Institute (NHLI), Imperial College London & Royal Brompton Hospital, South Block, Royal Brompton Campus, Sydney St, Chelsea, London, SW3 6NP, UK. o.usmani@imperial.ac.uk.
Nicolas RocheRespiratory Medicine, Hôpital Cochin (AP-HP), University of Paris, Cochin Institute, Paris, France.
Ezanul WahabSimbec Research Ltd, Merthyr Tydfil, UK.
Samuel IsraelSimbec Research Ltd, Merthyr Tydfil, UK.
Martin JenkinsAstraZeneca, Cambridge, UK.
Roopa TrivediAstraZeneca, Durham, NC, USA.
Paul DorinskyAstraZeneca, Durham, NC, USA.
Magnus AurivilliusAstraZeneca, Gothenburg, Sweden.
AstraZeneca (United States) · USAstraZeneca (Sweden) · SEAstraZeneca (United Kingdom) · GBRoyal Brompton Hospital · GBUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTriple therapy with inhaled corticosteroids/long-acting muscarinic antagonists/long-acting β

methodsThis phase I, single-dose, open-label gamma scintigraphy imaging study (NCT03906045) was conducted in patients with moderate-to-very severe COPD. Patients received two actuations of BGF MDI (160/9/4.8 μg per actuation) radiolabeled with technetium‑99‑pertechnetate, not exceeding 5 MBq per actuation. Immediately following each inhalation, patients performed a breath-hold of up to 10 s, then exhaled into an exhalation filter. Gamma scintigraphy imaging of the anterior and posterior views of the lungs and stomach, and a lateral head and neck view, were performed immediately after exhalation. The primary objective of the study was to assess the pulmonary deposition of BGF. Secondary objectives assessed the deposited dose of radiolabeled BGF in the oropharyngeal and stomach regions, on the actuator, and on the exhalation filter in addition to regional airway deposition patterns in the lungs.

resultsThe mean BGF emitted dose deposited in the lungs was 32.1% (standard deviation [SD] 15.6) in patients with moderate-to-very severe COPD, 35.2% (SD 12.8) in patients with moderate COPD, and 28.7% (SD 18.4) in patients with severe/very severe COPD. Overall, the mean normalized outer/inner ratio was 0.55 (SD 0.19), while the standardized central/peripheral ratio was 2.21 (SD 1.64).

conclusionsRadiolabeled BGF 320/18/9.6 μg was efficiently delivered and deposited throughout the entire lung, including large and small airways, in patients with moderate-to-very severe COPD, with similar deposition in patients with moderate COPD and patients with severe/very severe COPD.

trial registrationClinicalTrials.gov, NCT03906045. Registered 8 April 2019, https://clinicaltrials.gov/ct2/show/NCT03906045.

Indexed as

Adrenergic beta-2 Receptor AgonistsBronchodilator AgentsGlucocorticoidsLungMuscarinic AntagonistsPulmonary Disease, Chronic ObstructiveAdministration, InhalationAgedBudesonideContrast MediaDrug CombinationsFemaleFormoterol FumarateGlycopyrrolateHumansMaleAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsBudesonidebudesonide-glycopyrrolate-formoterol fumarate drug combinationContrast MediaDrug CombinationsFormoterol FumarateGlucocorticoidsGlycopyrrolateMuscarinic AntagonistsSodium Pertechnetate Tc 99mBudesonideFormoterol fumarateGamma scintigraphyGlycopyrroniumPulmonary deposition

Identifiers

PMID34620167
PMCPMC8496011
OpenAlexW3204567627

What OpenQuestion holds

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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.