Evidence map›Paper›PMID 26585525›Full record

Trial reportThorax2016

Blood eosinophils and inhaled corticosteroid/long-acting β-2 agonist efficacy in COPD.

Ian D Pavord, Sally Lettis, Nicholas Locantore, Steve Pascoe, Paul W Jones, Jadwiga A Wedzicha, Neil C Barnes

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Thorax, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03084718 (An 8-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI), which is not on this map. Cited by 136 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
136citing papers in PubMed, 10 pooled it
36.6field-weighted citation impact, top 1% 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.

NCT03084718 phase2completednot on this mapstarted 2017, after this paper: background citation

An 8-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 3 Doses of CHF 718 pMDI (HFA Beclomethasone Dipropionate Via Pressured Metered Dose Inhaler) in Asthmatic Subjects.

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2017 to 2018Enrolled610ConditionsAsthmaArmsCHF 718 pMDI, Placebo pMDI, Beclomethasone Dipropionate (BDP)
3 · Its place in the literature

Who cites it

136 citing papers in PubMed, 10 syntheses or guidelines pooled it, 319 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Romanian clinical guideline for diagnosis and treatment of COPD.The Journal of international medical research · 2020
    Guideline
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Blood eosinophils and inhaled corticosteroids in patients with COPD: systematic review and meta-analysis.International journal of chronic obstructive pulmonary disease · 2018
    Pooled it
  9. Pooled it
  10. Guideline
  11. Trial
  12. Trial
  13. The development of AZD7624 for prevention of exacerbations in COPD: a randomized controlled trial.International journal of chronic obstructive pulmonary disease · 2018
    Trial
  14. Trial
  15. Fluticasone propionate/formoterol for COPD management: a randomized controlled trial.International journal of chronic obstructive pulmonary disease · 2017
    Trial
  16. Trial
  17. Review
  18. Review
  19. Review
  20. Review

76 more citing papers are in PubMed but not listed here.

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 at 6 institutions in 3 countries.

Ian D PavordRespiratory Medicine Unit, Nuffield Department of Clinical Medicine, University of Oxford, Oxford, UK.
Sally LettisGSK, Uxbridge, UK.
Nicholas LocantoreRespiratory Medicine Development Center, GSK, Research Triangle Park, North Carolina, USA.
Steve PascoeRespiratory Medicine Development Center, GSK, Research Triangle Park, North Carolina, USA.
Paul W JonesSt George's, University of London, London, UK.
Jadwiga A WedzichaNational Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.
Neil C BarnesRespiratory Medical Franchise, GSK, Uxbridge, UK William Harvey Institute, Barts and The London School of Medicine and Dentistry, London, UK.
GlaxoSmithKline (China) · CNImperial College London · GBResearch Triangle Park Foundation · USSt George's, University of London · GBUniversity of Oxford · GBWilliam Harvey Research Institute · GB

Funding

Medical Research Council G0800570Medical Research Council G1001365Medical Research Council G1001372
6 · The paper itself

Abstract

objectiveWe performed a review of studies of fluticasone propionate (FP)/salmeterol (SAL) (combination inhaled corticosteroid (ICS)/long-acting β2-agonist (LABA)) in patients with COPD, which measured baseline (pretreatment) blood eosinophil levels, to test whether blood eosinophil levels ≥2% were associated with a greater reduction in exacerbation rates with ICS therapy.

methodsThree studies of ≥1-year duration met the inclusion criteria. Moderate and severe exacerbation rates were analysed according to baseline blood eosinophil levels (<2% vs ≥2%). At baseline, 57-75% of patients had ≥2% blood eosinophils. Changes in FEV1 and St George's Respiratory Questionnaire (SGRQ) scores were compared by eosinophil level.

resultsFor patients with ≥2% eosinophils, FP/SAL was associated with significant reductions in exacerbation rates versus tiotropium (INSPIRE: n=719, rate ratio (RR)=0.75, 95% CI 0.60 to 0.92, p=0.006) and versus placebo (TRISTAN: n=1049, RR=0.63, 95% CI 0.50 to 0.79, p<0.001). No significant difference was seen in the <2% eosinophil subgroup in either study (INSPIRE: n=550, RR=1.18, 95% CI 0.92 to 1.51, p=0.186; TRISTAN: n=354, RR=0.99, 95% CI 0.67 to 1.47, p=0.957, respectively). In SCO30002 (n=373), no significant effects were observed (FP or FP/SAL vs placebo). No relationship was observed in any study between eosinophil subgroup and treatment effect on FEV1 and SGRQ. DISCUSSION: Baseline blood eosinophil levels may represent an informative marker for exacerbation reduction with ICS/LABA in patients with COPD and a history of moderate/severe exacerbations.

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsDelayed-Action PreparationsDouble-Blind MethodEosinophilsFemaleFluticasone-Salmeterol Drug CombinationForced Expiratory VolumeGlucocorticoidsHumansMaleMiddle AgedPulmonary Disease, Chronic ObstructiveRetrospective StudiesSeverity of Illness IndexSurveys and QuestionnairesAdrenergic beta-2 Receptor AgonistsDelayed-Action PreparationsFluticasone-Salmeterol Drug CombinationGlucocorticoidsCOPD Exacerbations

Identifiers

PMID26585525
PMCPMC4752631
OpenAlexW2172490363

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.