Evidence map›Paper›PMID 30214185›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2018

A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD.

Wilfried De Backer, Jan De Backer, Wim Vos, Ilse Verlinden, Cedric Van Holsbeke, Johan Clukers, Bita Hajian, Shahid Siddiqui, Martin Jenkins, Colin Reisner and 1 more

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

Trial report in International journal of chronic obstructive pulmonary disease, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02643082 (A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing), which is not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.7field-weighted citation impact, top 6% 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.

NCT02643082 phase3completednot on this map

A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Single-Center Study to Evaluate the Effects of PT003 and Placebo MDI on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD

TypeinterventionalSponsorPearl Therapeutics, Inc.Ran2015 to 2017Enrolled20ConditionsCOPDArmsGFF MDI (PT003) 14.4/9.6μg, Placebo MDI
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 27 citations in OpenAlex.

  1. Trial
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  4. Article
  5. Review
  6. Article
  7. CT-Based Commercial Software Applications: Improving Patient Care Through Accurate COPD Subtyping.International journal of chronic obstructive pulmonary disease · 2022
    Review
  8. Article
  9. Review
  10. Article
  11. Article
  12. Article
  13. Review
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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

11 authors at 6 institutions in 4 countries.

Wilfried De BackerDepartment of Respiratory Medicine, University of Antwerp, Antwerp, Belgium, wilfried.debacker@uantwerpen.be.
Jan De BackerFLUIDDA, Los Angeles, CA, USA.
Wim VosFLUIDDA, Kontich, Belgium.
Ilse VerlindenFLUIDDA, Kontich, Belgium.
Cedric Van HolsbekeFLUIDDA, Kontich, Belgium.
Johan ClukersDepartment of Respiratory Medicine, University of Antwerp, Antwerp, Belgium, wilfried.debacker@uantwerpen.be.
Bita HajianDepartment of Respiratory Medicine, University of Antwerp, Antwerp, Belgium, wilfried.debacker@uantwerpen.be.
Shahid SiddiquiAstraZeneca, Gaithersburg, MD, USA.
Martin JenkinsAstraZeneca, Cambridge, UK.
Colin ReisnerAstraZeneca, Gaithersburg, MD, USA.
Ubaldo J MartinAstraZeneca, Gaithersburg, MD, USA.
Fluidda (Belgium) · BEUniversity of Antwerp · BEAstraZeneca (United States) · USAstraZeneca (Poland) · PLAstraZeneca (United Kingdom) · GBFluidda (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Functional respiratory imaging (FRI) uses high-resolution computed tomography (HRCT) scans to assess changes in airway volume and resistance. Patients and methods: In this randomized, double-blind, 2-week, crossover, Phase IIIB study, patients with moderate-to-severe COPD received twice-daily glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler (GFF MDI, 18/9.6 μg) and placebo MDI, formulated using innovative co-suspension delivery technology. Co-primary endpoints included the following: specific image-based airway volume (siVaw) and specific image-based airway resistance (siRaw) at Day 15, measured using FRI. Secondary and other endpoints included the following: change from baseline in post-dose forced expiratory volume in 1 second (FEV Results: Twenty patients (46-78 years of age) were randomized and treated; of whom 19 completed the study. GFF MDI treatment increased siVaw by 75% and reduced siRaw by 71% vs placebo MDI (both Conclusion: GFF MDI demonstrated significant, clinically meaningful benefits on FRI-based airway volume and resistance in patients with moderate-to-severe COPD. Benefits were associated with improvements in FEV Clinical trial registration: ClinicalTrials.gov: NCT02643082.

Indexed as

RespirationAdministration, InhalationAdultAgedAged, 80 and overBelgiumBronchodilator AgentsDouble-Blind MethodForced Expiratory VolumeFormoterol FumarateGermanyGlycopyrrolateHumansLondonMaleMetered Dose InhalersBronchodilator AgentsFormoterol FumarateGlycopyrrolateairway resistanceairway volumeGFF MDIhyperinflationinspiratory capacityLAMA/LABA

Identifiers

PMID30214185
PMCPMC6124470
OpenAlexW2889394978

What OpenQuestion holds

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LicenceCC BY-NC
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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.