Evidence map›Paper›PMID 30220648›Full record

Trial reportThe European respiratory journal2018

Budesonide/formoterol MDI with co-suspension delivery technology in COPD: the TELOS study.

Gary T Ferguson, Alberto Papi, Antonio Anzueto, Edward M Kerwin, Christy Cappelletti, Elizabeth A Duncan, Jack Nyberg, Paul Dorinsky

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The European respiratory journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02766608 (A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort® Turbuhaler®, as an Active Control, on Lung Function Over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD), which is not on this map. Cited by 17 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 7 pooled it
1.6field-weighted citation impact, top 15% 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.

NCT02766608 phase3completednot on this map

A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005, PT008, and Open-label Symbicort® Turbuhaler®, as an Active Control, on Lung Function Over a 24-Week Treatment Period in Subjects With Moderate to Very Severe COPD

TypeinterventionalSponsorPearl Therapeutics, Inc.Ran2016 to 2017Enrolled2,389ConditionsChronic Obstructive Pulmonary DisorderArmsBFF MDI 320/9.6 μg, BFF MDI 160/9.6 μg, FF MDI 9.6 μg, BD MDI 320 μg, Symbicort® TBH 400/12 μg BID
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 7 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Race-Based Pulmonary Function Testing Correction in COPD Inhaler Therapy Trials: A Systematic Review.International journal of chronic obstructive pulmonary disease · 2024
    Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Article
  9. Article
  10. Article
  11. Discordant diagnostic criteria for pneumonia in COPD trials: a review.European respiratory review : an official journal of the European Respiratory Society · 2021
    Review
  12. Review
  13. Article
  14. Formoterol for the Treatment of Chronic Obstructive Pulmonary Disease.International journal of chronic obstructive pulmonary disease · 2020
    Review
  15. Dual Bronchodilator in the Era of Triple Therapy.International journal of chronic obstructive pulmonary disease · 2020
    Review
  16. Observational
  17. 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

8 authors at 5 institutions in 4 countries.

Gary T FergusonPulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.
Alberto PapiResearch Centre on Asthma and COPD, Dept of Medical Sciences, University of Ferrara, Ferrara, Italy.ORCID 0000-0002-6924-4500
Antonio AnzuetoPulmonary Medicine and Critical Care, University of Texas Health Science Center and South Texas Veterans Health Care System, San Antonio, TX, USA.
Edward M KerwinClinical Research Institute of Southern Oregon, Medford, OR, USA.
Christy CappellettiPearl - a member of the AstraZeneca Group, Durham, NC, USA.
Elizabeth A DuncanPearl - a member of the AstraZeneca Group, Durham, NC, USA.
Jack NybergPearl - a member of the AstraZeneca Group, Morristown, NJ, USA.
Paul DorinskyPearl - a member of the AstraZeneca Group, Durham, NC, USA.
AstraZeneca (Netherlands) · NLAstraZeneca (Poland) · PLClinical Research Institute · USThe University of Texas Health Science Center at San Antonio · USUniversity of Ferrara · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

TELOS compared budesonide (BD)/formoterol fumarate dihydrate (FF) metered dose inhaler (BFF MDI), formulated using innovative co-suspension delivery technology that enables consistent aerosol performance, with its monocomponents and budesonide/formoterol fumarate dihydrate dry powder inhaler (DPI) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), without a requirement for an exacerbation history.In this phase III, double-blind, parallel-group, 24-week study (NCT02766608), patients were randomised to BFF MDI 320/10 µg (n=664), BFF MDI 160/10 µg (n=649), FF MDI 10 µg (n=648), BD MDI 320 µg (n=209) or open-label budesonide/formoterol DPI 400/12 µg (n=219). Primary end-points were change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV

Indexed as

Administration, InhalationAgedBronchodilator AgentsBudesonideDouble-Blind MethodDrug Therapy, CombinationFemaleForced Expiratory VolumeFormoterol FumarateHumansInternationalityMaleMetered Dose InhalersMiddle AgedPulmonary Disease, Chronic ObstructiveTreatment OutcomeBronchodilator AgentsBudesonideFormoterol Fumarate

Identifiers

PMID30220648
PMCPMC6383599
OpenAlexW2890960652

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.