Evidence map›Paper›PMID 32041601›Full record

Trial reportRespiratory research2020

A dose-ranging study of the inhaled dual phosphodiesterase 3 and 4 inhibitor ensifentrine in COPD.

Dave Singh, Fernando J Martinez, Henrik Watz, Thomas Bengtsson, Brian T Maurer

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 3 pooled it
3.7field-weighted citation impact, top 5% 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.

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

31 citing papers in PubMed, 3 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
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  6. Trial
  7. Review
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  16. Review
  17. Perspectives on Ensifentrine and Its Therapeutic Potential in the Treatment of COPD: Evidence to Date.International journal of chronic obstructive pulmonary disease · 2024
    Review
  18. Advances in metabolomics of chronic obstructive pulmonary disease.Chinese medical journal pulmonary and critical care medicine · 2023
    Review
  19. A New Treatment for Chronic Obstructive Pulmonary Disease: Ensifentrine Moves Closer.American journal of respiratory and critical care medicine · 2023
    Article
  20. 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

5 authors at 4 institutions in 3 countries.

Dave SinghMedicines Evaluation Unit, University of Manchester & Manchester University NHS Foundation Trust, Manchester, UK. dsingh@meu.org.uk.
Fernando J MartinezWeill Cornell Medical College, New York, New York, and University of Michigan School of Medicine, Ann Arbor, MI, USA.
Henrik WatzPulmonary Research Institute at Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Grosshansdorf, Germany.
Thomas BengtssonStatMind AB, Lund, Sweden.
Brian T MaurerVerona Pharma plc, London, UK.
Cornell University · USGerman Center for Lung Research · DEManchester University NHS Foundation Trust · GBVerona Pharma (United Kingdom) · GB

Funding

Verona Pharma plc N/A
6 · The paper itself

Abstract

backgroundMany patients with chronic obstructive pulmonary disease (COPD) still experience daily symptoms, exacerbations, and accelerated lung function decline, even when receiving maximal combined treatment with inhaled long-acting bronchodilators and corticosteroids. Novel treatment options are needed for these patients. Phosphodiesterases (PDEs) are enzymes that impact a range of cellular functions by modulating levels of cyclic nucleotides, and there is evidence to suggest that combined inhibition of PDE3 and PDE4 can have additive (or perhaps synergistic) effects. This study investigated the efficacy and safety of ensifentrine, a first-in-class dual inhibitor of PDE 3 and 4, in patients with COPD.

methodsThis randomised, double-blind, placebo-controlled, parallel-group, dose-ranging study recruited patients with COPD, post-bronchodilator forced expiratory volume in 1 s (FEV PRIMARY OUTCOME: placebo-adjusted difference in peak FEV

resultsThe study took place between July 2017 and February 2018. Of 405 patients randomly assigned to medication, 375 (92.6%) completed the study. For peak FEV

conclusionsIn this four-week Phase IIb study, all four ensifentrine doses significantly improved bronchodilation and symptoms, with a dose-ranging effect from 0.75 to 3 mg twice daily, and all doses well tolerated. The study supports the continuing development of ensifentrine in COPD.

trial registrationEudraCT 2016-005205-40, registered 30 May 2017.

Indexed as

Administration, InhalationAdultAgedBronchodilator AgentsDose-Response Relationship, DrugDouble-Blind MethodFemaleForced Expiratory VolumeHumansIsoquinolinesMaleMiddle AgedPhosphodiesterase 3 InhibitorsPhosphodiesterase 4 InhibitorsPulmonary Disease, Chronic ObstructivePyrimidinonesBronchodilator AgentsensifentrineIsoquinolinesPhosphodiesterase 3 InhibitorsPhosphodiesterase 4 InhibitorsPyrimidinonesChronic obstructive pulmonary diseasePhosphodiesterase inhibitorsSafetySpirometrySymptoms

Identifiers

PMID32041601
PMCPMC7011474
OpenAlexW3008746762

What OpenQuestion holds

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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.