Evidence map›Paper›PMID 33883890›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease

Peak Inspiratory Flow Rate in COPD: An Analysis of Clinical Trial and Real-World Data.

Martin Anderson, Kathryn Collison, M Bradley Drummond, Melanie Hamilton, Renu Jain, Neil Martin, Richard A Mularski, Mike Thomas, Chang-Qing Zhu, Gary T Ferguson

2 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.6field-weighted citation impact, top 9% 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.

NCT03478683 phase4completednot on this map

A Phase IV, 12-week, Randomised, Double-blind, Triple Dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) With Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorGlaxoSmithKlineRan2018 to 2019Enrolled729ConditionsPulmonary Disease, Chronic ObstructiveArmsbudesonide/formoterol, albuterol/salbutamol, FF/UMEC/VI, Placebo to match budesonide/formoterol, tiotropium
NCT03478696 phase4completednot on this map

A Phase IV, 12-week, Randomised, Double-blind, Triple Dummy Study to Compare Single Inhaler Triple Therapy, Fluticasone Furoate/Umeclidinium/Vilanterol (FF/UMEC/VI) With Multiple Inhaler Therapy (Budesonide/Formoterol Plus Tiotropium) Based on Lung Function and Symptoms in Participants With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorGlaxoSmithKlineRan2018 to 2019Enrolled732ConditionsPulmonary Disease, Chronic ObstructiveArmsbudesonide/formoterol, albuterol/salbutamol, FF/UMEC/VI, Placebo to match budesonide/formoterol, tiotropium
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 24 citations in OpenAlex.

  1. Trial
  2. Observational
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. Successful Use of EasyhalerPulmonary therapy · 2024
    Article
  12. Journal of aerosol medicine and pulmonary drug delivery · 2023
    Article
  13. Article
  14. Article
  15. Measuring Peak Inspiratory Flow in Patients with Chronic Obstructive Pulmonary Disease.International journal of chronic obstructive pulmonary disease
    Review
  16. Article
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

10 authors at 7 institutions in 3 countries.

Martin AndersonDepartment of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0002-7776-9307
Kathryn CollisonRespiratory Therapy Area, GSK, Research Triangle Park, NC, USA.
M Bradley DrummondPulmonary and Critical Care Medicine, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.ORCID 0000-0002-6968-4610
Melanie HamiltonR&D, GSK, Ware, Hertfordshire, UK.
Renu JainRespiratory Therapy Area, GSK, Research Triangle Park, NC, USA.ORCID 0000-0001-5400-2536
Neil MartinGlobal Medical Affairs, GSK, Brentford, Middlesex, UK.
Richard A MularskiDepartment of Pulmonary and Critical Care Medicine, Kaiser Permanente Northwest Center for Health Research, Portland, OR, USA.ORCID 0000-0001-6979-2542
Mike ThomasPrimary Care Research, University of Southampton, Southampton, UK.
Chang-Qing ZhuBiostatistics, GSK, Stockley Park West, Uxbridge, Middlesex, UK.ORCID 0000-0003-0142-3534
Gary T FergusonPulmonary Research, Institute of Southeast Michigan, Farmington Hills, MI, USA.
Research Triangle Park Foundation · USKaiser Permanente Center for Health Research · USKarolinska Institutet · SEUniversity of Hertfordshire · GBUniversity of Leicester · GBUniversity of North Carolina at Chapel Hill · USUniversity of Southampton · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe influence of peak inspiratory flow (PIF) on dose delivery from dry powder inhalers (DPIs) and association with treatment efficacy in patients with chronic obstructive pulmonary disease (COPD) has not been fully determined. In vitro studies have demonstrated adequate dose delivery through ELLIPTA DPI at PIF ≥30 L/min. This analysis of two clinical trials and a real-world population of COPD patients determined spirometric PIF distribution, and explored the relationship between PIF and outcomes in the trials.

methodsThe replicate Phase IV, 12-week, randomized, double-blind 207608/207609 (NCT03478683/NCT03478696) trials evaluated fluticasone furoate/umeclidinium/vilanterol via ELLIPTA DPI versus budesonide/formoterol+tiotropium in COPD patients. This post hoc analysis assessed spirometric PIF distribution at screening and relationship between PIF and lung function outcomes in the pooled 207608/207609 population. Spirometric PIF distributions in a real-world population of COPD patients were evaluated by retrospective analysis of the Kaiser Permanente Northwest (KPNW) database to assess similarities between clinical trial and real-world populations.

resultsA total of 1460 (207608/207609) and 3282 (KPNW) patients were included. There was considerable overlap between spirometric PIF distributions for both populations. Overall, 99.7% and 99.8% of the 207608/207609 and KPNW populations, respectively, reported spirometric PIF ≥50 L/min, estimated as equivalent to ELLIPTA PIFR ≥30 L/min. In the 207608/207609 combined analysis, there was no significant interaction between spirometric PIF and treatment for lung function endpoints, indicating treatment effect is independent of PIF.

conclusionNearly all COPD patients in the 207608/207609 and KPNW populations achieved spirometric PIF values estimated as equivalent to PIFR of ≥30 L/min through the ELLIPTA DPI. Lack of correlation between spirometric PIF at screening and treatment efficacy aligns with consistent dose performance from the ELLIPTA DPI across a wide range of PIFs, achieved by patients with COPD of all severities.

Indexed as

Pulmonary Disease, Chronic ObstructiveAdministration, InhalationBronchodilator AgentsDry Powder InhalersHumansRetrospective StudiesSpirometryBronchodilator AgentsCOPDDPIinhaled triple therapypatient outcomespeak inspiratory flow ratereal-world studies

Identifiers

PMID33883890
PMCPMC8055277
OpenAlexW3156685480

What OpenQuestion holds

Textmetadata
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.