Evidence map›Paper›PMID 37803368›Full record

ArticleRespiratory research2023

The effect of inhaled extrafine beclometasone dipropionate/formoterol fumarate/glycopyrronium bromide on distal and central airway indices, assessed using Functional Respiratory Imaging in COPD (DARWiIN).

Gwen S Skloot, Alessandro Guasconi, Benjamin R Lavon, George Georges, Wilfried De Backer, Dmitry Galkin, Mauro Cortellini, Ilaria Panni, Jason H T Bates

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Respiratory research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04876677 (Open Label, Prospective Study to Evaluate the Effect of Step-up From Non-extra Fine Inhaled Corticosteroids/Long Acting Beta2 Agonist), which is not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.8field-weighted citation impact, top 24% 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.

NCT04876677 phase3completednot on this map

Open Label, Prospective Study to Evaluate the Effect of Step-up From Non-extra Fine Inhaled Corticosteroids/Long Acting Beta2 Agonist (ICS/LABA) Dry Powder Inhaler (DPI) to Extra Fine Triple Therapy With CHF5993 DPI on Airway Geometry and Lung Ventilation Using Functional Respiratory Imaging (FRI) in Subjects With Advanced Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2021 to 2022Enrolled25ConditionsChronic Obstructive Pulmonary DiseaseArmsBeclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium (BDP/FF/GB)
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Review
  3. Article
  4. 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

9 authors at 4 institutions in 3 countries.

Gwen S SklootGlobal Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy. gwen.skloot@chiesi.com.
Alessandro GuasconiGlobal Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.
Benjamin R LavonFLUIDDA, Kontich, Belgium.
George GeorgesGlobal Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.
Wilfried De BackerDepartment of Respiratory Medicine, University of Antwerp, Antwerp, Belgium.
Dmitry GalkinGlobal Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.
Mauro CortelliniGlobal Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.
Ilaria PanniGlobal Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.
Jason H T BatesDepartments of Medicine, Larner College of Medicine, University of Vermont, Burlington, VT, USA.
Chiesi (Italy) · ITFluidda (Belgium) · BEUniversity of Antwerp · BEUniversity of Vermont · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study, in patients with symptomatic chronic obstructive pulmonary disease (COPD), explored switching therapy from non-extrafine high-dose inhaled corticosteroid/long-acting β

methodsPatients receiving a stable ICS/LABA regimen for ≥ 8 weeks were switched to FP/SLM 500/50 µg, one inhalation twice-daily (high-dose ICS) for 6 weeks. After baseline assessments (Visit 2 [V2]), therapy was switched to BDP/FF/G 100/6/10 µg, two inhalations twice-daily (medium-dose ICS) for 6 weeks, followed by V3. The primary endpoints were percentage changes in specific image-based airway volume (siV

resultsThere were no significant changes in pre-dose siV

conclusionsIn patients with symptomatic COPD receiving high-dose ICS/LABA, adding a long-acting muscarinic antagonist while decreasing the ICS dose by switching to medium-dose extrafine BDP/FF/G was associated with improved airway indices, especially in the distal airways, together with improvements in respiratory health status. Trial registration ClinicalTrials.gov (NCT04876677), first posted 6th May 2021.

Indexed as

GlycopyrrolatePulmonary Disease, Chronic ObstructiveAdministration, InhalationAdrenergic beta-2 Receptor AgonistsBeclomethasoneBronchodilator AgentsDrug CombinationsFluticasone-Salmeterol Drug CombinationFormoterol FumarateHumansMuscarinic AntagonistsAdrenergic beta-2 Receptor AgonistsBeclomethasoneBronchodilator AgentsDrug CombinationsFluticasone-Salmeterol Drug CombinationFormoterol FumarateGlycopyrrolateMuscarinic Antagonists

Identifiers

PMID37803368
PMCPMC10559640
OpenAlexW4387408751

What OpenQuestion holds

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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.