Evidence map›Paper›PMID 30880943›Full record

ArticleInternational journal of chronic obstructive pulmonary disease

Extrafine triple therapy delays COPD clinically important deterioration vs ICS/LABA, LAMA, or LABA/LAMA.

Dave Singh, Leonardo M Fabbri, Stefano Vezzoli, Stefano Petruzzelli, Alberto Papi

3 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article 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 3 registered trials, which are not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 8% 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.

NCT01911364 phase3completednot on this map

A 52-wk Randomized Double Blind Parallel Trial: Combination of Beclometasone+Formoterol+Glycopyrrolate vs Tiotropium and vs Combination of Beclometasone+Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2014 to 2016Enrolled3,686ConditionsChronic Obstructive Pulmonary DiseaseArmsBDP/FF/GB, Tiotropium, BDP/FF + Tiotropium
NCT01917331 phase3completednot on this map

A Phase 3 Randomised Double Blind Randomised Parallel Multinational Trial Comparing a Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate to Foster® in Patients With Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2014 to 2016Enrolled1,368ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsBeclometasone/Formoterol/Glycopyrrolate, Beclometasone/Formoterol
NCT02579850 phase3completednot on this map

52-week, Double Blind, Randomized, 2 Active Parallel Arms Study of Fixed Combination CHF 5993 Administered vs Ultibro® in COPD Patients

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2015 to 2017Enrolled1,532ConditionsChronic Obstructive Pulmonary Disease (COPD)ArmsCHF 5993 + Ultibro matched placebo, Ultibro + CHF 5993 matched placebo, Central spirometry, COPD assessment test, Local laboratory Assessments
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Review
  9. Article
  10. Review
  11. Article
  12. Day and Night Control of COPD and Role of Pharmacotherapy: A Review.International journal of chronic obstructive pulmonary disease · 2020
    Review
  13. Article
  14. 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

5 authors at 3 institutions in 4 countries.

Dave SinghMedicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Trust, Manchester, UK, dsingh@meu.org.uk.
Leonardo M FabbriSection of Cardiorespiratory and Internal Medicine, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.
Stefano VezzoliGlobal Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.
Stefano PetruzzelliGlobal Clinical Development, Chiesi Farmaceutici SpA, Parma, Italy.
Alberto PapiSection of Cardiorespiratory and Internal Medicine, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.
Chiesi (Italy) · ITUniversity of Ferrara · ITManchester University NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCurrent pharmacological therapies for COPD improve quality of life and symptoms and reduce exacerbations. Given the progressive nature of COPD, it is arguably more important to understand whether the available therapies are able to delay clinical deterioration; the concept of "clinically important deterioration" (CID) has therefore been developed. We evaluated the efficacy of the single-inhaler triple combination beclometasone dipropionate, formoterol fumarate, and glycopyrronium (BDP/FF/G), using data from three large 1-year studies.

methodsThe studies compared BDP/FF/G to BDP/FF (TRILOGY), tiotropium (TRINITY), and indacaterol/glycopyrronium (IND/GLY; TRIBUTE). All studies recruited patients with symptomatic COPD, FEV

resultsExtrafine BDP/FF/G significantly extended the time to first CID vs BDP/FF (HR 0.61,

conclusionIn patients with symptomatic COPD, FEV

trial registrationThe studies are registered in ClinicalTrials.gov: TRILOGY, NCT01917331; TRINITY, NCT01911364; TRIBUTE, NCT02579850.

Indexed as

Administration, InhalationAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsAgedBeclomethasoneBronchodilator AgentsDisease ProgressionDrug CombinationsFemaleForced Expiratory VolumeFormoterol FumarateGlycopyrrolateHumansLungMaleMiddle AgedAdrenal Cortex HormonesAdrenergic beta-2 Receptor AgonistsBeclomethasoneBronchodilator AgentsDrug CombinationsFormoterol FumarateGlycopyrrolateMuscarinic Antagonistsanticholinergicsbeta-2 agonistschronic obstructive pulmonary diseasedisease activityinhaled corticosteroids

Identifiers

PMID30880943
PMCPMC6400232
OpenAlexW2917301053

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.