Evidence map›Paper›PMID 26329916›Full record

Trial reportClinical drug investigation2015

Is Blood Eosinophil Count a Predictor of Response to Bronchodilators in Chronic Obstructive Pulmonary Disease? Results from Post Hoc Subgroup Analyses.

Ahmar Iqbal, Neil C Barnes, Jean Brooks

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Clinical drug investigation, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 2 pooled it
–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

6 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Day and Night Control of COPD and Role of Pharmacotherapy: A Review.International journal of chronic obstructive pulmonary disease · 2020
    Review
  6. Are blood eosinophils a prime-time biomarker for COPD management decisions?International journal of chronic obstructive pulmonary disease · 2018
    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.

Ahmar IqbalRespiratory Franchise Medical, GSK, 5 Moore Drive, 5.3317, Research Triangle Park, NC, USA.
Neil C BarnesRespiratory Medical Franchise, GSK, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex, UB11 1BT, UK. neil.c.barnes@gsk.com.
Jean BrooksRespiratory Medicines Development Centre, GSK, Stockley Park West, 1-3 Ironbridge Road, Uxbridge, Middlesex, UB11 1BT, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundChronic obstructive pulmonary disease (COPD) patients with blood eosinophil (EOS) count ≥ 2% benefit from exacerbation reductions with inhaled corticosteroids (ICSs). We conducted post hoc analyses to determine if EOS count ≥ 2% is a marker for greater responsiveness to the bronchodilators umeclidinium (UMEC; long-acting muscarinic antagonist), vilanterol (VI; long-acting β2-agonist) or UMEC/VI combination.

methodsEffects of once-daily UMEC/VI 62.5/25, UMEC 62.5 and VI 25 µg versus placebo on trough forced expiratory volume in one second (FEV1), Transition Dyspnoea Index (TDI), St George's Respiratory Questionnaire (SGRQ) scores and adverse event (AE) incidences in four completed, 6-month studies were assessed by EOS subgroup. Trough FEV1 was also evaluated by ICS use and EOS subgroup. Analyses were performed using a repeated measures model.

resultsAt baseline, 2437 of 4647 (52%) patients had EOS count ≥ 2%. Overall, ≈ 50% of patients used ICSs. At day 169, no notable variations were observed in trough FEV1 least squares mean differences between EOS subgroups versus placebo for UMEC/VI, UMEC and VI; results according to ICS use were similar. No differences were reported between EOS subgroups in TDI and SGRQ scores on day 168, or for incidences of AEs, serious AEs and AEs leading to withdrawal.

conclusionsResponse to UMEC/VI, UMEC and VI in terms of trough FEV1, dyspnoea and health-related quality of life was similar for COPD patients with baseline EOS counts ≥ 2 or <2%. EOS count did not appear to predict bronchodilator response in either ICS users or non-users.

Indexed as

Adrenergic beta-2 Receptor AgonistsAgedBenzyl AlcoholsBronchodilator AgentsChlorobenzenesDouble-Blind MethodDrug CombinationsEosinophilsFemaleForced Expiratory VolumeHumansLeukocyte CountMaleMiddle AgedMuscarinic AntagonistsPredictive Value of TestsAdrenergic beta-2 Receptor AgonistsBenzyl AlcoholsBronchodilator AgentsChlorobenzenesDrug CombinationsGSK573719Muscarinic AntagonistsQuinuclidinesvilanterol

Identifiers

PMID26329916
PMCPMC4579251

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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.