Evidence map›Paper›PMID 30786914›Full record

Trial reportBMC research notes2019

Does device matter for inhaled therapies in advanced chronic obstructive pulmonary disease (COPD)? A comparative trial of two devices.

Haider Mannan, Soo Wei Foo, Belinda Cochrane

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC research notes, 2019. 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. Review
  2. 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

3 authors.

Haider MannanTranslational Health Research Institute, Western Sydney University, Campbelltown, NSW, Australia. h.mannan@westernsydney.edu.au.
Soo Wei FooSchool of Medicine, Western Sydney University, Campbelltown, NSW, Australia.
Belinda CochraneSchool of Medicine, Western Sydney University, Campbelltown, NSW, Australia.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveCOPD patients have challenges for effective use of inhalers due to advanced age, fixed airflow obstruction and comorbid medical conditions. Published clinical trials investigate drug efficacy but rarely consider the inhaler device. This trial investigates device efficacy, comparing clinical outcomes for the same medication via two different devices. Our intention was to communicate the results and to critically appraise the study protocol to inform planning of future device comparison research. Subjects with spirometry confirming at least moderate COPD were randomly assigned to inhaler sequence; starting with Accuhaler or metered dose inhaler and spacer (MDI/s). After baseline testing, subjects were assigned to fluticasone propionate/salmeterol xinafoate (SFC) 500/50 mcg twice daily via the first device for 6 weeks' duration, then changed to the alternate device for the following 6 weeks. Subjects were reassessed in terms of health-related quality of life (HRQL), exercise endurance and lung function after each exposure period.

resultsThe recruitment target was not achieved due to unanticipated developments within the pharmaceutical industry, potentially compromising the study's power. Study outcomes did not differ significantly according to the allocated inhaler device even after adjusting for baseline lung function or inhaler technique. Recommendations for future device comparison protocols are offered. Trial registration Australia and New Zealand Clinical Trials Registry, Current Controlled Trials ACTRN12618000075280, date of registration: 18.01.2018. Retrospectively registered.

Indexed as

Metered Dose InhalersOutcome Assessment, Health CareAgedBronchodilator AgentsCross-Over StudiesFemaleFluticasoneHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveSalmeterol XinafoateSingle-Blind MethodBronchodilator AgentsFluticasoneSalmeterol XinafoateAssessor-blind methodChronic obstructiveCross overInhalation devicesPulmonary diseaseQuality of life

Identifiers

PMID30786914
PMCPMC6383223

What OpenQuestion holds

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LicenceCC BY
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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.