Evidence map›Paper›PMID 33757520›Full record

Trial reportRespiratory research2021

Efficacy and safety of single-inhaler extrafine triple therapy versus inhaled corticosteroid plus long-acting beta2 agonist in eastern Asian patients with COPD: the TRIVERSYTI randomised controlled trial.

Jinping Zheng, Simonetta Baldi, Li Zhao, Huiping Li, Kwan-Ho Lee, Dave Singh, Alberto Papi, Frédérique Grapin, Alessandro Guasconi, George Georges

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Respiratory research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03197818 (A 24-week, Double Blind, Double Dummy, Randomized, Multinational, Multicentre, 2-arm Parallel Group,Active Controlled Clinical Trial of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide Administered Via pMDI), which is not on this map. Cited by 10 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 4 pooled it
1.9field-weighted citation impact, top 14% 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.

NCT03197818 phase3completednot on this map

A 24-week, Double Blind, Double Dummy, Randomized, Multinational, Multicentre, 2-arm Parallel Group,Active Controlled Clinical Trial of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide Administered Via pMDI (CHF 5993) Versus the Fixed Combination of Budesonide Plus Formoterol Fumarate (Symbicort® Turbuhaler®) in Patients With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2016 to 2020Enrolled708ConditionsCOPD (Chronic Obstructive Pulmonary Disease)ArmsCHF 5993 100/6/12.5 µg, 160 µg budesonide + 4.5 µg formoterol fumarate
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 4 syntheses or guidelines pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Review
  7. Article
  8. Smoking cessation and vaccination.European respiratory review : an official journal of the European Respiratory Society · 2023
    Article
  9. Article
  10. Observational
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

10 authors at 7 institutions in 5 countries.

Jinping ZhengState Key Laboratory of Respiratory Disease, National Clinical Research Centre for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.
Simonetta BaldiGlobal Clinical Development, Chiesi Farmaceutici SpA, Largo Belloli, 11\a, 43122, Parma, Italy.
Li ZhaoShengjing Hospital of China Medical University, Shenyang, China.
Huiping LiShanghai Pulmonary Hospital, Shanghai, China.
Kwan-Ho LeeYeungnam University Medical Center, Daegu, Republic of Korea.
Dave SinghMedicines Evaluation Unit, The University of Manchester, Manchester University NHS Foundations Trust, Manchester, UK.
Alberto PapiRespiratory Medicine Unit, University of Ferrara, University Hospital S. Anna, Ferrara, Italy.
Frédérique GrapinGlobal Clinical Development, Chiesi Farmaceutici SpA, Largo Belloli, 11\a, 43122, Parma, Italy.
Alessandro GuasconiGlobal Clinical Development, Chiesi Farmaceutici SpA, Largo Belloli, 11\a, 43122, Parma, Italy.
George GeorgesGlobal Clinical Development, Chiesi Farmaceutici SpA, Largo Belloli, 11\a, 43122, Parma, Italy. george.georges@chiesi.com.ORCID http://orcid.org/0000-0002-0303-2273
Chiesi (Italy) · ITChina Medical University · CNFirst Affiliated Hospital of Guangzhou Medical University · CNShanghai Pulmonary Hospital · CNUniversity of Ferrara · ITUniversity of Manchester · GBYeungnam University Medical Center · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA single-inhaler extrafine triple combination of beclometasone dipropionate (BDP), formoterol fumarate (FF) and glycopyrronium (G) has been developed for maintenance therapy of chronic obstructive pulmonary disease (COPD). This study evaluated the efficacy and safety of BDP/FF/G in patients in three eastern Asian areas: China, Republic of Korea and Taiwan.

methodsTRIVERSYTI was a double-blind, randomised, active-controlled, parallel-group study in patients with COPD, post-bronchodilator forced expiratory volume in 1 s (FEV

resultsOf 708 patients randomised, 88.8% completed. BDP/FF/G was superior to BUD/FF for pre-dose and 2-h post-dose FEV

conclusionsIn patients with COPD, FEV

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsAgedBeclomethasoneBronchodilator AgentsChinaDisease ProgressionDouble-Blind MethodDrug CombinationsDry Powder InhalersFemaleForced Expiratory VolumeFormoterol FumarateGlucocorticoidsGlycopyrrolateHumansAdrenergic beta-2 Receptor AgonistsBeclomethasoneBronchodilator AgentsDrug CombinationsFormoterol FumarateGlucocorticoidsGlycopyrrolateMuscarinic AntagonistsAirway obstructionChronic bronchitisChronic obstructive pulmonary diseaseExtrafineTriple inhalation therapy

Identifiers

PMID33757520
PMCPMC7989027
OpenAlexW3137141754

What OpenQuestion holds

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LicenceCC BY
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.