Evidence map›Paper›PMID 26355743›Full record

ArticleJournal of aerosol medicine and pulmonary drug delivery2016

Effect of Flow Rate on In Vitro Aerodynamic Performance of NEXThaler(®) in Comparison with Diskus(®) and Turbohaler(®) Dry Powder Inhalers.

Francesca Buttini, Gaetano Brambilla, Diego Copelli, Viviana Sisti, Anna Giulia Balducci, Ruggero Bettini, Irene Pasquali

Registry-linked trialOpen access · bronzeAbstract readComparative Study
In one paragraph

Article in Journal of aerosol medicine and pulmonary drug delivery, 2016. 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 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
6.9field-weighted citation impact, top 2% 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.

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

35 citing papers in PubMed, 110 citations in OpenAlex.

  1. Trial
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  12. Usability of inhaler devices: a parameter currently misused.Multidisciplinary respiratory medicine · 2024
    Article
  13. Article
  14. Article
  15. Feedback systems in multi-dose dry powder inhalers.Postepy dermatologii i alergologii · 2023
    Review
  16. Article
  17. Article
  18. Article
  19. 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

7 authors at 3 institutions in 2 countries.

Francesca Buttini1 Department of Pharmacy, University of Parma , Parma, Italy .
Gaetano Brambilla3 Chiesi Farmaceutici SpA , Parma, Italy .
Diego Copelli3 Chiesi Farmaceutici SpA , Parma, Italy .
Viviana Sisti3 Chiesi Farmaceutici SpA , Parma, Italy .
Anna Giulia Balducci4 Interdepartmental Center, Biopharmanet-TEC, University of Parma , Parma, Italy .
Ruggero Bettini1 Department of Pharmacy, University of Parma , Parma, Italy .
Irene Pasquali3 Chiesi Farmaceutici SpA , Parma, Italy .
Chiesi (Italy) · ITUniversity of Parma · ITKing's College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEuropean and United States Pharmacopoeia compendial procedures for assessing the in vitro emitted dose and aerodynamic size distribution of a dry powder inhaler require that 4.0 L of air at a pressure drop of 4 kPa be drawn through the inhaler. However, the product performance should be investigated using conditions more representative of what is achievable by the patient population. This work compares the delivered dose and the drug deposition profile at different flow rates (30, 40, 60, and 90 L/min) of Foster NEXThaler(®) (beclomethasone dipropionate/formoterol fumarate), Seretide(®) Diskus(®) (fluticasone propionate/salmeterol xinafoate), and Symbicort(®) Turbohaler(®) (budesonide/formoterol fumarate).

methodsThe delivered dose uniformity was tested using a dose unit sampling apparatus (DUSA) at inhalation volumes either 2.0 or 4.0 L and flow rates 30, 40, 60, or 90 L/min. The aerodynamic assessment was carried out using a Next Generation Impactor by discharging each inhaler at 30, 40, 60, or 90 L/min for a time sufficient to obtain an air volume of 4 L.

resultsFoster(®) NEXThaler(®) and Seretide(®) Diskus(®) showed a consistent dose delivery for both the drugs included in the formulation, independently of the applied flow rate. Contrary, Symbicort(®) Turbohaler(®) showed a high decrease of the emitted dose for both budesonide and formoterol fumarate when the device was operated at airflow rate lower that 60 L/min. The aerosolizing performance of NEXThaler(®) and Diskus(®) was unaffected by the flow rate applied. Turbohaler(®) proved to be the inhaler most sensitive to changes in flow rate in terms of fine particle fraction (FPF) for both components. Among the combinations tested, Foster NEXThaler(®) was the only one capable to deliver around 50% of extra-fine particles relative to delivered dose.

conclusionsNEXThaler(®) and Diskus(®) were substantially unaffected by flow rate through the inhaler in terms of both delivered dose and fine particle mass.

Indexed as

Dry Powder InhalersAdministration, InhalationAerosolsBeclomethasoneBronchodilator AgentsBudesonide, Formoterol Fumarate Drug CombinationEquipment DesignFluticasone-Salmeterol Drug CombinationFormoterol FumarateGlucocorticoidsMaterials TestingParticle SizePowdersPressureTime FactorsAerosolsBeclomethasoneBronchodilator AgentsBudesonide, Formoterol Fumarate Drug CombinationFluticasone-Salmeterol Drug CombinationFormoterol FumarateGlucocorticoidsPowdersaerodynamic assessmentDiskus®extra-fine particle massNEXThaler®NGI flow rateTurbohaler®

Identifiers

PMID26355743
PMCPMC4841907
OpenAlexW2329577524

What OpenQuestion holds

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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.