Evidence map›Paper›PMID 30880951›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease

Randomized dose-finding study of batefenterol via dry powder inhaler in patients with COPD.

Courtney Crim, Michael L Watkins, Eric D Bateman, Gregory J Feldman, Isabelle Schenkenberger, Edward M Kerwin, Catriona Crawford, Krishna Pudi, Shuyen Ho, Charlotte Baidoo and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of chronic obstructive pulmonary disease. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02570165 (Study 201012), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 20% 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.

NCT02570165 phase2completednot on this map

Study 201012: A Dose-Finding Study of Batefenterol (GSK961081) Via Dry Powder Inhaler in Patients With COPD

TypeinterventionalSponsorGlaxoSmithKlineRan2015 to 2016Enrolled325ConditionsPulmonary Disease, Chronic ObstructiveArmsBatefenterol, Umeclidinium/ Vilanterol, Placebo
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 9 citations in OpenAlex.

  1. The future of inhalation therapy in chronic obstructive pulmonary disease.Current research in pharmacology and drug discovery · 2022
    Review
  2. Review
  3. Review
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

11 authors at 7 institutions in 5 countries.

Courtney CrimGSK, Research and Development, Research Triangle Park, NC, USA, courtney.c.crim@gsk.com.
Michael L WatkinsGSK, Research and Development, Research Triangle Park, NC, USA, courtney.c.crim@gsk.com.
Eric D BatemanDivision of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Gregory J FeldmanS. Carolina Pharmaceutical Research, Spartanburg, SC, USA.
Isabelle SchenkenbergerKlinische Forschung Berlin GbR, Berlin, Germany.
Edward M KerwinClinical Trials Division, Crisor LLC, Clinical Research Institute, Medford OR, USA.
Catriona CrawfordGSK, Global Medical, Stockley Park, Uxbridge, Middlesex, UK.
Krishna PudiUpstate Pharmaceutical Research, Greenville, SC, USA.
Shuyen HoPAREXEL International, Durham, NC, USA.
Charlotte BaidooGSK, Clinical Statistics, Stockley Park, Uxbridge, Middlesex, UK.
Ramiro Castro-SantamariaGSK, Research and Development, Collegeville, PA, USA.
Research Triangle Park Foundation · USMiddlesex University · GBClinical Research Institute · USGesellschaft für Klinische Forschung · DEGlaxoSmithKline (United States) · USPAREXEL International (United Kingdom) · GBUniversity of Cape Town · ZA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBatefenterol is a novel bifunctional muscarinic antagonist β PATIENTS AND

methodsPatients aged ≥40 years with COPD and FEV

resultsIn the intent-to-treat population (N=323), all batefenterol doses demonstrated statistically and clinically significant improvements from baseline vs placebo in the primary and secondary endpoints (191.1-292.8 and 182.2-244.8 mL, respectively), with a relatively flat dose-response. In the subgroup reversible to salbutamol, there were greater differences between batefenterol doses. Lung function improvements with batefenterol ≥150 µg were comparable with those with UMEC/VI. Batefenterol was well tolerated and no new safety signals were observed.

conclusionBatefenterol 300 µg may represent the optimal dose for Phase III studies.

Indexed as

Dry Powder InhalersAdministration, InhalationAdrenergic beta-2 Receptor AgonistsAdultAgedCarbamatesDose-Response Relationship, DrugDouble-Blind MethodFemaleForced Expiratory VolumeGermanyHumansLungMaleMiddle AgedMuscarinic AntagonistsAdrenergic beta-2 Receptor AgonistsbatefenterolCarbamatesMuscarinic AntagonistsQuinolonesbifunctionalbronchodilatordose-responsedual-pharmacophoremuscarinic antagonist β2-agonist

Identifiers

PMID30880951
PMCPMC6413745
OpenAlexW2920650592

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.