Evidence map›Paper›PMID 34113093›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2021

An Inhaled PI3Kδ Inhibitor Improves Recovery in Acutely Exacerbating COPD Patients: A Randomized Trial.

Anthony Cahn, J Nicole Hamblin, Jon Robertson, Malcolm Begg, Emily Jarvis, Robert Wilson, Gordon Dear, Claudia Leemereise, Yi Cui, Maki Mizuma and 6 more

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02294734 (A Randomised, Double-blind), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.9field-weighted citation impact, top 13% 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.

NCT02294734 phase2completednot on this map

A Randomised, Double-blind (Sponsor Unblinded), Placebo-controlled, Parallel-group, Multicentre Study to Evaluate the Efficacy and Safety of GSK2269557 Administered in Addition to Standard of Care in Adult Subjects Diagnosed With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorGlaxoSmithKlineRan2015 to 2016Enrolled126ConditionsPulmonary Disease, Chronic ObstructiveArmsGSK2269557, Placebo
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 17 citations in OpenAlex.

  1. Nemiralisib in Patients with an Acute Exacerbation of COPD: Placebo-Controlled, Dose-Ranging Study.International journal of chronic obstructive pulmonary disease · 2021
    Trial
  2. Review
  3. Article
  4. Review
  5. Review
  6. Novel Anti-Inflammatory Approaches to COPD.International journal of chronic obstructive pulmonary disease · 2023
    Review
  7. Article
  8. Pathological Mechanism and Targeted Drugs of COPD.International journal of chronic obstructive pulmonary disease · 2022
    Review
  9. CT-Based Commercial Software Applications: Improving Patient Care Through Accurate COPD Subtyping.International journal of chronic obstructive pulmonary disease · 2022
    Review
  10. 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

16 authors at 5 institutions in 4 countries.

Anthony CahnDiscovery Medicine, GlaxoSmithKline, Stevenage, UK.
J Nicole HamblinRefractory Respiratory Inflammation Discovery Performance Unit, GlaxoSmithKline, Stevenage, UK.
Jon RobertsonBiostatistics, GlaxoSmithKline, Stevenage, UK.
Malcolm BeggRefractory Respiratory Inflammation Discovery Performance Unit, GlaxoSmithKline, Stevenage, UK.ORCID 0000-0001-9508-3424
Emily JarvisBiostatistics, GlaxoSmithKline, Stevenage, UK.ORCID 0000-0001-7187-6382
Robert WilsonDiscovery Medicine, GlaxoSmithKline, Stevenage, UK.
Gordon DearMechanistic Safety & Disposition, GlaxoSmithKline, Ware, UK.
Claudia LeemereiseGlobal Clinical Sciences & Delivery, GlaxoSmithKline, Amersfoort, the Netherlands.
Yi CuiPharma Safety, GlaxoSmithKline, Brentford, Middlesex, UK.
Maki MizumaData Management & Strategy, GlaxoSmithKline, Tokyo, Japan.
Mickael MontembaultGlobal Clinical Sciences & Delivery, GlaxoSmithKline, Brentford, Middlesex, UK.
Cedric Van HolsbekeFLUIDDA nv, Kontich, 2550, Belgium.ORCID 0000-0003-0248-841X
Wim VosFLUIDDA nv, Kontich, 2550, Belgium.
Wilfried De BackerPulmonary Medicine & Pulmonary Rehabilitation, University of Antwerp, Antwerp, Belgium.
Jan De BackerFLUIDDA nv, Kontich, 2550, Belgium.
Edith M HesselRefractory Respiratory Inflammation Discovery Performance Unit, GlaxoSmithKline, Stevenage, UK.ORCID 0000-0002-2339-4482
GlaxoSmithKline (United Kingdom) · GBFluidda (Belgium) · BEGlaxoSmithKline (Japan) · JPGlaxoSmithKline (Netherlands) · NLUniversity of Antwerp · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: This study evaluated the safety and efficacy of inhaled nemiralisib, a phosphoinositide 3-kinase δ (PI3Kδ) inhibitor, in patients with an acute exacerbation of chronic obstructive pulmonary disease (COPD). Methods: In this double-blind, placebo-controlled study, 126 patients (40-80 years with a post-bronchodilator forced expiratory volume in 1 sec (FEV Results: A total of 126 patients were randomized to treatment; 55 on active treatment and 49 on placebo completed the study. When comparing nemiralisib and placebo-treated patients, an 18% placebo-corrected increase from baseline in distal siVaw (95% credible intervals (Cr I) (-1%, 42%)) was observed on Day 28. The probability that the true treatment ratio was >0% (Pr(θ>0)) was 96%, suggestive of a real treatment effect. Improvements were observed across all lung lobes. Patients treated with nemiralisib experienced a 107.3 mL improvement in posterior median FEV Conclusion: These data show that addition of nemiralisib to usual care delivers more effective recovery from an acute exacerbation and improves lung function parameters including siVaw and FEV

Indexed as

Phosphatidylinositol 3-KinasesPulmonary Disease, Chronic ObstructiveAdministration, InhalationBayes TheoremBronchodilator AgentsDouble-Blind MethodForced Expiratory VolumeHumansTreatment OutcomeBronchodilator AgentsPhosphatidylinositol 3-Kinasesacute exacerbationCOPDnemiralisib

Identifiers

PMID34113093
PMCPMC8184151
OpenAlexW3172802917

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.