Evidence map›Paper›PMID 35969632›Full record

Trial reportPloS one2022

Correct use and ease-of-use of placebo ELLIPTA dry-powder inhaler in adult patients with chronic obstructive pulmonary disease.

Thomas M Siler, Renu Jain, Kathryn Collison, Raj Sharma, Laura Sutton, Jamie Rees, David I Bernstein

Abstract readClinical Trial
In one paragraph

Trial report in PloS one, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. 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

7 authors.

Thomas M SilerMidwest Chest Consultants, St Charles, Missouri, United States of America.ORCID 0000-0002-5103-0360
Renu JainUS Medical Affairs, GSK, Research Triangle Park, Durham, North Carolina, United States of America.ORCID 0000-0001-5400-2536
Kathryn CollisonUS Medical Affairs, GSK, Research Triangle Park, Durham, North Carolina, United States of America.
Raj SharmaRespiratory Medical Franchise, GSK, Brentford, United Kingdom.
Laura SuttonUS Medical Affairs, GSK, Research Triangle Park, Durham, North Carolina, United States of America.
Jamie ReesBiostatistics, Respiratory, GSK, Brentford, United Kingdom.
David I BernsteinDivision of Immunology, Allergy and Rheumatology University of Cincinnati College of Medicine and Bernstein Clinical Research Center, Cincinnati, Ohio, United States of America.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundInhaler technique errors are common in chronic obstructive pulmonary disease (COPD) treatment, potentially leading to poor disease management. Our pooled analysis approach assessed correct use and ease-of-use of a placebo ELLIPTA dry-powder inhaler (DPI) in patients with COPD.

methodsAdults with COPD from open-label/non-blinded studies evaluating a placebo ELLIPTA DPI and reporting outcomes of correct use (based on the ELLIPTA DPI patient information leaflet [PIL]) and/or ease-of-use were included. Correct use and ease-of use at study end were primary and secondary endpoints, respectively. Data from patients in the placebo ELLIPTA DPI arm of each study were pooled, and the intent-to-treat (ITT) population was used for all analyses.

resultsFour placebo ELLIPTA DPI studies, reporting correct use (n = 4) and ease-of-use (n = 2), were included in the analysis. The ITT population comprised 1232 patients (mean age 66.2 years). For the primary endpoint, 80.1% (n = 975/1217) of patients demonstrated correct use at study end (95% confidence interval [CI]: 77.8%-82.3%). For the secondary endpoint, 95.7% (n = 797/833) of patients rated placebo ELLIPTA DPI use "easy"/"very easy" at study end (95% CI: 94.1%-97.0%). Correct use and "easy"/"very easy" user ratings remained high across younger (40-64 years) and older (≥65 years) age groups.

conclusionsAcross age groups, most patients used the placebo ELLIPTA DPI correctly and rated it "easy"/"very easy" to use. Consistent with the Global Initiative for Chronic Obstructive Lung Disease 2021 report, our findings emphasize that proper training and clear instructions on PILs are important for optimal inhaler use.

Indexed as

Dry Powder InhalersPulmonary Disease, Chronic ObstructiveAdministration, InhalationAdultAgedBronchodilator AgentsEquipment DesignHumansPowdersBronchodilator AgentsPowders

Identifiers

PMID35969632
PMCPMC9377593

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Registered trials

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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.