Evidence map›Paper›PMID 31253162›Full record

Trial reportRespiratory research2019

Evaluation of systemic absorption and bronchodilator effect of glycopyrronium bromide delivered by nebulizer or a dry powder inhaler in subjects with chronic obstructive pulmonary disease.

Brian R Leaker, Dave Singh, Grant C Nicholson, Blanka Hezelova, Thomas Goodin, Ayca Ozol-Godfrey, Gerald Galluppi, Peter J Barnes

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Respiratory research, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02512302 (A Crossover Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of SUN-101 and Seebri® Breezhaler® Administered With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 23% 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.

NCT02512302 phase1completednot on this map

A Crossover Clinical Pharmacology Study to Evaluate the Total Systemic Exposure and Lung Bioavailability of SUN-101 and Seebri® Breezhaler® Administered With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorSunovion Respiratory Development Inc.Ran2015 to 2016Enrolled30ConditionsCOPDArmsSUN-101 via eFlow nebulizer, SUN-101 via eFlow nebulizer with activated charcoal, Seebri® Breezhaler®, Seebri® Breezhaler® with activated charcoal, Glycopyrrolate Injection
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Review
  5. Future Trends in Nebulized Therapies for Pulmonary Disease.Journal of personalized medicine · 2020
    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

8 authors at 5 institutions in 2 countries.

Brian R LeakerRespiratory Clinical Trials Ltd, 20 Queen Anne Street, London, W1G 8HU, UK. brian.leaker@qasmc.com.
Dave SinghMedicines Evaluation Unit, Manchester University NHS Foundations Trust, University of Manchester, Manchester, UK.
Grant C NicholsonRespiratory Clinical Trials Ltd, 20 Queen Anne Street, London, W1G 8HU, UK.
Blanka HezelovaRespiratory Clinical Trials Ltd, 20 Queen Anne Street, London, W1G 8HU, UK.
Thomas GoodinSunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Ayca Ozol-GodfreySunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Gerald GalluppiSunovion Pharmaceuticals Inc., Marlborough, MA, USA.
Peter J BarnesNational Heart and Lung Institute, Imperial College London, London, UK.
Respiratory Clinical Trials · GBSunovion (United States) · USImperial College London · GBUniversity of Manchester · GBVion Pharmaceuticals (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEffective bronchodilator therapy depends upon adequate drug deposition in the lung. COPD patients who are unable to administer medications efficiently with conventional inhalers may benefit from the use of a nebulizer device. The aim of this study was to evaluate the systemic bioavailability and bronchodilator response of glycopyrronium bromide (GLY) administered by a novel nebulizer (eFlow® closed system [CS] vibrating membrane nebulizer) or dry powder inhaler (DPI) in subjects with moderate-to-severe chronic obstructive pulmonary disease (COPD).

methodsIn this randomized, open-label, single-dose, five-way crossover study, subjects received a sequence of either 50 μg GLY delivered by eFlow CS nebulizer (GLY/eFlow) or 63 μg GLY delivered by DPI (GLY/DPI), with and without activated charcoal, followed by intravenous infusion of 50 μg GLY with a washout period of 7 days between doses. Endpoints included plasma pharmacokinetics, safety and efficacy.

resultsThe mean (± SD) baseline predicted forced expiratory volume in 1 s (FEV

conclusionsAfter single doses, GLY/DPI delivered numerically higher peak and steady state levels of drug than did GLY/eFlow. Nebulized GLY produced similar bronchodilation but lower systemic levels of drug than GLY/DPI. Slightly higher number of subjects reported adverse events with GLY/DPI than with GLY/eFlow. Nebulized GLY may offer an effective alternative to patients with COPD not adequately treated with other devices.

trial registrationNCT02512302 (ClinicalTrials.gov). Registered 28 May 2015.

Indexed as

Administration, InhalationAdultAgedBronchodilator AgentsCross-Over StudiesDrug Delivery SystemsDry Powder InhalersFemaleGlycopyrrolateHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveTreatment OutcomeBronchodilator AgentsGlycopyrrolateBioavailabilityCOPDGlycopyrronium bromideNebulizer

Identifiers

PMID31253162
PMCPMC6599298
OpenAlexW2954330635

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.