Evidence map›Paper›PMID 26372465›Full record

ArticleJournal of aerosol medicine and pulmonary drug delivery2015

In Vitro Dosing Performance of the ELLIPTA® Dry Powder Inhaler Using Asthma and COPD Patient Inhalation Profiles Replicated with the Electronic Lung (eLung™).

Melanie Hamilton, Richard Leggett, Cheng Pang, Stephen Charles, Ben Gillett, David Prime

Registry-linked trialAbstract read
In one paragraph

Article in Journal of aerosol medicine and pulmonary drug delivery, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05445349 (Measurement of Breathing Parameters of Asthma and COPD Patients With Different Degrees of Disease Severity for the Computer Simulation of Lung Deposition of Aerosol Drugs), which is not on this map. Cited by 25 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT05445349 completednot on this mapstarted 2022, after this paper: background citation

Measurement of Breathing Parameters of Asthma and COPD Patients With Different Degrees of Disease Severity for the Computer Simulation of Lung Deposition of Aerosol Drugs

TypeobservationalSponsorMedisol Development Kft.Ran2022 to 2025Enrolled163ConditionsAsthma, COPDArmsEmptied dry powder inhalers (DPI) used in routine asthma and COPD therapy
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Peak Inspiratory Flow Rate in COPD: An Analysis of Clinical Trial and Real-World Data.International journal of chronic obstructive pulmonary disease
    Trial
  5. Randomized dose-finding study of batefenterol via dry powder inhaler in patients with COPD.International journal of chronic obstructive pulmonary disease
    Trial
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  7. Observational
  8. Review
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  16. Journal of aerosol medicine and pulmonary drug delivery · 2023
    Article
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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

6 authors.

Melanie HamiltonGSK Research and Development Ltd , Ware, Hertfordshire, United Kingdom .
Richard LeggettGSK Research and Development Ltd , Ware, Hertfordshire, United Kingdom .
Cheng PangGSK Research and Development Ltd , Ware, Hertfordshire, United Kingdom .
Stephen CharlesGSK Research and Development Ltd , Ware, Hertfordshire, United Kingdom .
Ben GillettGSK Research and Development Ltd , Ware, Hertfordshire, United Kingdom .
David PrimeGSK Research and Development Ltd , Ware, Hertfordshire, United Kingdom .

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo evaluate the in vitro dose delivery characteristics of approved asthma and chronic obstructive pulmonary disease (COPD) therapies delivered via the ELLIPTA(®) dry powder inhaler across inhalation endpoints representative of the target patient population, using the Electronic Lung (eLung™) to replicate inhaler-specific patient inhalation profiles that were previously recorded in vivo.

methodsSelected profiles, representative of the range of inhalation endpoints achieved by patients with all severities of asthma and COPD, were replicated using the eLung breathing simulator in conjunction with an oropharyngeal cast. A Next Generation Impactor was coupled to the eLung to determine the aerodynamic particle size distribution of the ex-throat dose (ETD) of asthma and COPD therapies delivered via the ELLIPTA inhaler. Delivered dose (DD), ETD, and fine particle dose (FPD; defined as a mass of active substance less than 5 μm) were determined for fluticasone furoate (FF)/vilanterol (VI) 100/25 μg and 200/25 μg (asthma and COPD), umeclidinium (UMEC)/VI 62.5/25 μg (COPD only), FF 100 μg and 200μg monotherapy (asthma only), and UMEC 62.5 μg monotherapy (COPD only).

resultsInhalation profiles replicated by eLung covered a wide range of peak inspiratory flow rates (41.6-136.9 L/min), pressure drops (1.2-13.8 kPa), and inhaled volumes through the inhaler (0.7-4.2L). DD was consistent across the range of patient representative inhalation parameters for all components (FF, VI, and UMEC) of each therapy assessed; although ETD and FPD were also generally consistent, some small variation was observed. Dose delivery was consistent for each of the components, whether delivered as mono- or combination therapy.

conclusionsThe in vitro performance of the ELLIPTA inhaler has been demonstrated for the delivery of FF/VI, UMEC/VI, FF monotherapy, and UMEC monotherapy. Across a range of inspiratory profiles, DD was consistent, while ETD and FPD showed little flow dependency.

Indexed as

Dry Powder InhalersInhalationAdministration, InhalationAerosolsAndrostadienesAsthmaBenzyl AlcoholsBronchodilator AgentsChlorobenzenesClinical Trials as TopicDrug CombinationsDrug Delivery SystemsEquipment DesignHumansLungModels, AnatomicAerosolsAndrostadienesBenzyl AlcoholsBronchodilator AgentsChlorobenzenesDrug Combinationsfluticasone furoateGSK573719PowdersQuinuclidinesvilanterolasthmaCOPDdelivered dosedry powder inhalerelectronic lungfine particle doseinhalation profiles

Identifiers

PMID26372465
PMCPMC4685503

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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.