Evidence map›Paper›PMID 29138555›Full record

Trial reportInternational journal of chronic obstructive pulmonary disease2017

The efficacy of extrafine beclomethasone dipropionate-formoterol fumarate in COPD patients who are not "frequent exacerbators": a post hoc analysis of the FORWARD study.

Dave Singh, Stefano Vezzoli, Stefano Petruzzelli, Alberto Papi

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

Trial report in International journal of chronic obstructive pulmonary disease, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00929851 (a 48-week, Double Blind, Randomized, Multinational, Multicentre, "Fixed Combination" Beclomethasone Dipropionate Plus Formoterol Fumarate Versus Formoterol in Patients With Severe Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.4field-weighted citation impact, top 32% 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.

NCT00929851 phase3completednot on this map

a 48-week, Double Blind, Randomized, Multinational, Multicentre, "Fixed Combination" Beclomethasone Dipropionate Plus Formoterol Fumarate Versus Formoterol in Patients With Severe Chronic Obstructive Pulmonary Disease

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2009 to 2012Enrolled1,199ConditionsPulmonary Disease, Chronic ObstructiveArmsCHF1535, Formoterol fumarate
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. 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

4 authors at 3 institutions in 3 countries.

Dave SinghMedicines Evaluation Unit, University of Manchester, Manchester, UK.
Stefano VezzoliChiesi Farmaceutici SpA, Parma.
Stefano PetruzzelliChiesi Farmaceutici SpA, Parma.
Alberto PapiSection of Respiratory Diseases, University of Ferrara, Ferrara, Italy.
Chiesi Foundation · ITUniversity of Ferrara · ITUniversity of Manchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The GOLD 2017 strategy document recommends that the pharmacological management of COPD patients be based on the risk of future exacerbations and the severity of symptoms. A threshold of two moderate exacerbations or one hospitalization is used to define high-risk patients. The FORWARD study was a randomized, double-blind, parallel-group trial that compared 48 weeks' treatment with extrafine beclomethasone dipropionate plus formoterol fumarate (BDP-FF) versus FF in severe COPD patients with a history of one or more exacerbations in the previous year. The new GOLD 2017 recommendations mean that many patients in the FORWARD study are now reclassified as GOLD B. We conducted a post hoc analysis of the FORWARD study, in order to investigate the effects of extrafine BDP/FF in patients with one exacerbation in the previous year, focusing on those categorized as group B using the GOLD 2017 definition. The analysis showed a 35% reduction in exacerbation rate with an inhaled corticosteroid (ICS) + long-acting β-agonist (LABA) versus LABA. We propose that ICS-LABA treatment is a therapeutic option for COPD patients with one exacerbation in the previous year.

Indexed as

Administration, InhalationAdrenergic beta-2 Receptor AgonistsBeclomethasoneDisease ProgressionDouble-Blind MethodDrug CombinationsFormoterol FumarateGlucocorticoidsHumansLungParticle SizePulmonary Disease, Chronic ObstructiveTime FactorsTreatment OutcomeAdrenergic beta-2 Receptor AgonistsBeclomethasoneDrug CombinationsFormoterol FumarateGlucocorticoidsCOPDcorticosteroidexacerbationsGOLD 2017GOLD B

Identifiers

PMID29138555
PMCPMC5680966
OpenAlexW2765856713

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.