Evidence map›Paper›PMID 32380894›Full record

Trial reportTherapeutic advances in respiratory disease

Functional respiratory imaging assessment of glycopyrrolate and formoterol fumarate metered dose inhalers formulated using co-suspension delivery technology in patients with COPD.

Wilfried De Backer, Jan De Backer, Ilse Verlinden, Glenn Leemans, Cedric Van Holsbeke, Benjamin Mignot, Martin Jenkins, Dianne Griffis, Stefan Ivanov, Jane Fitzpatrick and 3 more

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

Trial report in Therapeutic advances in respiratory disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02937584 (A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.0field-weighted citation impact, top 20% 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.

NCT02937584 phase3completednot on this map

A Randomized, Double-Blind, Two Treatment, Two Period, Chronic Dosing (2 Weeks), Cross-Over, Multi-Center Study to Evaluate the Effects of PT001 and PT005 on Specific Image Based Airway Volumes and Resistance in Subjects With Moderate to Severe COPD.

TypeinterventionalSponsorPearl Therapeutics, Inc.Ran2016 to 2018Enrolled23ConditionsCOPD, Chronic Obstructive Pulmonary DiseaseArmsGP MDI (PT001) 14.4 μg, FF MDI (PT005) 9.6 μg
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. CT-Based Commercial Software Applications: Improving Patient Care Through Accurate COPD Subtyping.International journal of chronic obstructive pulmonary disease · 2022
    Review
  5. Article
  6. 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

13 authors at 6 institutions in 4 countries.

Wilfried De BackerUniversity of Antwerp, Campus Drie Eiken, Universiteitsplein 1, Wilrijk, 2610 Antwerp, Belgium.
Jan De BackerFLUIDDA, Inc, Los Angeles, CA, USA.
Ilse VerlindenFormerly of FLUIDDA NV, Kontich, Belgium.
Glenn LeemansFormerly of FLUIDDA NV, Kontich, Belgium.
Cedric Van HolsbekeFLUIDDA NV, Kontich, Belgium.
Benjamin MignotFLUIDDA NV, Kontich, Belgium.
Martin JenkinsAstraZeneca, Cambridge, UK.
Dianne GriffisAstraZeneca, Durham, NC, USA.
Stefan IvanovAstraZeneca, Gothenburg, Sweden.
Jane FitzpatrickAstraZeneca, Morristown, NJ, USA.
Earl St RoseAstraZeneca, Morristown, NJ, USA.
Ubaldo J MartinAstraZeneca, Gaithersburg, MD, USA.
Colin ReisnerAstraZeneca, Morristown, NJ, USA.
AstraZeneca (United States) · USFluidda (Belgium) · BEAstraZeneca (Sweden) · SEAstraZeneca (United Kingdom) · GBFluidda (United States) · USUniversity of Antwerp · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFunctional respiratory imaging (FRI) is a quantitative postprocessing imaging technique used to assess changes in the respiratory system. Using FRI, we characterized the effects of the long-acting muscarinic antagonist (LAMA), glycopyrrolate metered dose inhaler (GP MDI), and the long-acting β

methodsPatients in this phase IIIb, randomized, double-blind crossover study received twice-daily GP MDI (18 μg) and FF MDI (9.6 μg). Primary endpoints were specific (i.e. corrected for lobar volume) image-based airway volume (siVaw) and specific image-based airway resistance (siRaw), measured using FRI. Secondary and other endpoints included additional FRI, spirometry, and body plethysmography parameters. Postdose efficacy assessments were performed within 60-150 min of dosing on day 15.

resultsA total of 23 patients were randomized and 19 completed both treatment periods. GP MDI and FF MDI both achieved significant improvements from baseline to day 15 in siVaw [11% (

conclusionBoth GP MDI and FF MDI significantly improved siRaw and siVaw at day 15 CLINICALTRIALS.GOV REGISTRATION NUMBER: NCT02937584

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsAgedAirway ResistanceBronchodilator AgentsCross-Over StudiesDouble-Blind MethodDrug CompoundingFemaleForced Expiratory VolumeFormoterol FumarateGlycopyrrolateHumansLungMaleMetered Dose InhalersAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsFormoterol FumarateGlycopyrrolateMuscarinic Antagonistsformoterol fumarate dihydratefunctional respiratory imagingglycopyrroniumlong-acting muscarinic antagonistlong-acting β2-agonist

Identifiers

PMID32380894
PMCPMC7225799
OpenAlexW3023851103

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.