Evidence map›Paper›PMID 29954359›Full record

Trial reportBMC pulmonary medicine2018

Evaluation of inhaler technique and achievement and maintenance of mastery of budesonide/formoterol Spiromax® compared with budesonide/formoterol Turbuhaler® in adult patients with asthma: the Easy Low Instruction Over Time (ELIOT) study.

David B Price, Vicky Thomas, P N Richard Dekhuijzen, Sinthia Bosnic-Anticevich, Nicolas Roche, Federico Lavorini, Priyanka Raju, Daryl Freeman, Carole Nicholls, Iain R Small and 4 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyPragmatic Clinical Trial
In one paragraph

Trial report in BMC pulmonary medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02570425 (THE HCP ELIOT STUDY), which is not on this map. Cited by 3 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 19% 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.

NCT02570425 nacompletednot on this map

THE HCP ELIOT STUDY: Comparing Maintenance of Device Mastery With TURBOHALER© vs. SPIROMAX© in Healthcare Professionals naïve to Both Devices (The Easy Low Instruction Over Time [ELIOT] Study)

TypeinterventionalSponsorResearch in Real-Life LtdRan2014 to 2015Enrolled516ConditionsAsthmaArmsTraining on BF Spiromax followed by SYMBICORT Turbohaler, Training on SYMBICORT Turbohaler followed by BF Spiromax
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. 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

14 authors at 8 institutions in 6 countries.

David B PriceObservational and Pragmatic Research Institute Pte Ltd, Singapore, Singapore. dprice@opri.sg.ORCID http://orcid.org/0000-0002-1195-039X
Vicky ThomasObservational and Pragmatic Research Institute Pte Ltd, Singapore, Singapore.
P N Richard DekhuijzenRadboud University Nijmegen Medical Center, Nijmegen, The Netherlands.
Sinthia Bosnic-AnticevichWoolcock Institute, University of Sydney and Sydney Local Health District, Sydney, NSW, Australia.
Nicolas RocheUniversity Paris Descartes, Paris, France.
Federico LavoriniUniversity of Florence, Florence, Italy.
Priyanka RajuObservational and Pragmatic Research Institute Pte Ltd, Singapore, Singapore.
Daryl FreemanObservational and Pragmatic Research Institute Pte Ltd, Singapore, Singapore.
Carole NichollsObservational and Pragmatic Research Institute Pte Ltd, Singapore, Singapore.
Iain R SmallObservational and Pragmatic Research Institute Pte Ltd, Singapore, Singapore.
Erika SimsObservational and Pragmatic Research Institute Pte Ltd, Singapore, Singapore.
Guilherme SafiotiTeva Pharmaceuticals Europe BV, Amsterdam, The Netherlands.
Janice CanvinTeva Pharmaceuticals Europe BV, Amsterdam, The Netherlands.
Henry ChrystynObservational and Pragmatic Research Institute Pte Ltd, Singapore, Singapore.
Observational & Pragmatic Research Institute · SGTeva Pharmaceuticals (Netherlands) · NLDélégation Paris 5 · FRRadboud University Nijmegen · NLThe University of Sydney · AUUniversity of Aberdeen · GBUniversity of East Anglia · GBUniversity of Florence · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIncorrect inhaler technique is a common cause of poor asthma control. This two-phase pragmatic study evaluated inhaler technique mastery and maintenance of mastery with DuoResp® (budesonide-formoterol [BF]) Spiromax® compared with Symbicort® (BF) Turbuhaler® in patients with asthma who were receiving inhaled corticosteroids/long-acting β2-agonists.

methodsIn the initial cross-sectional phase, patients were randomized to a 6-step training protocol with empty Spiromax and Turbuhaler devices. Patients initially demonstrating ≥1 error with their current device, and then achieving mastery with both Spiromax and Turbuhaler (absence of healthcare professional [HCP]-observed errors), were eligible for the longitudinal phase. In the longitudinal phase, patients were randomized to BF Spiromax or BF Turbuhaler. Co-primary endpoints were the proportions of patients achieving device mastery after three training steps and maintaining device mastery (defined as the absence of HCP-observed errors after 12 weeks of use). Secondary endpoints included device preference, handling error frequency, asthma control, and safety. Exploratory endpoints included assessment of device mastery by an independent external expert reviewing video recordings of a subset of patients.

resultsFour hundred ninety-three patients participated in the cross-sectional phase, and 395 patients in the longitudinal phase. In the cross-sectional phase, more patients achieved device mastery after three training steps with Spiromax (94%) versus Turbuhaler (87%) (odds ratio [OR] 3.77 [95% confidence interval (CI) 2.05-6.95], p < 0.001). Longitudinal phase data indicated that the odds of maintaining inhaler mastery at 12 weeks were not statistically significantly different (OR 1.26 [95% CI 0.80-1.98], p = 0.316). Asthma control improved in both groups with no significant difference between groups (OR 0.11 [95% CI -0.09-0.30]). An exploratory analysis indicated that the odds of maintaining independent expert-verified device mastery were significantly higher for patients using Spiromax versus Turbuhaler (OR 2.11 [95% CI 1.25-3.54]).

conclusionsIn the cross-sectional phase, a significantly greater proportion of patients using Spiromax versus Turbuhaler achieved device mastery; in the longitudinal phase, the proportion of patients maintaining device mastery with Spiromax versus Turbuhaler was similar. An exploratory independent expert-verified analysis found Spiromax was associated with higher levels of device mastery after 12 weeks. Asthma control was improved by treatment with both BF Spiromax and BF Turbuhaler.

trial registrationEudraCT 2013-004630-14 (registration date 23 January 2014); NCT02570425 .

Indexed as

AsthmaBudesonideBudesonide, Formoterol Fumarate Drug CombinationDry Powder InhalersFormoterol FumarateAdministration, InhalationAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsAdultAgedBronchodilator AgentsCross-Sectional StudiesFemaleHumansLogistic ModelsMaleAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsBronchodilator AgentsBudesonideBudesonide, Formoterol Fumarate Drug CombinationFormoterol FumarateAsthmaBudesonide/formoterolDry-powder inhalerInhaler masteryInhaler techniqueIntuitivePragmatic clinical trial

Identifiers

PMID29954359
PMCPMC6022306
OpenAlexW2810627873

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.