Evidence map›Paper›PMID 27309985›Full record

ReviewNPJ primary care respiratory medicine2016

Extrafine beclometasone diproprionate/formoterol fumarate: a review of its effects in chronic obstructive pulmonary disease.

Dave Singh, Massimo Corradi, Monica Spinola, Stefano Petruzzelli, Alberto Papi

Registry-linked trialOpen access · goldAbstract readReview
In one paragraph

Review in NPJ primary care respiratory medicine, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00476099 (A 48-week, Double Blind, Double Dummy, Randomised, Multinational, Multicentre, 3-arm Parallel Group Clinical Study of "Fixed Combination" Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant Versus "Fixed Combination" Budesonide Plus Formoterol DPI Versus Formoterol DPI in Patients With Stable Severe Chronic Obstructive Pulmonary Disease), which is not on this map. Cited by 11 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 1 pooled it
4.4field-weighted citation impact, top 5% 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.

NCT00476099 phase3completednot on this map

A 48-week, Double Blind, Double Dummy, Randomised, Multinational, Multicentre, 3-arm Parallel Group Clinical Study of "Fixed Combination" Beclometasone Dipropionate Plus Formoterol Fumarate Administered Via pMDI With HFA-134a Propellant Versus "Fixed Combination" Budesonide Plus Formoterol DPI Versus Formoterol DPI in Patients With Stable Severe Chronic Obstructive Pulmonary Disease (COPD)

TypeinterventionalSponsorChiesi Farmaceutici S.p.A.Ran2006 to 2008Enrolled828ConditionsChronic Obstructive Pulmonary DiseaseArmsBeclomethasone 100 µg plus formoterol 6 µg (CHF1535) pMDI, Budesonide 200 µg plus formoterol 6 µg DPI, Formoterol 12 µg DPI
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Guideline
  2. Trial
  3. Trial
  4. Fluticasone propionate/formoterol for COPD management: a randomized controlled trial.International journal of chronic obstructive pulmonary disease · 2017
    Trial
  5. Review
  6. How inhaled corticosteroids target inflammation in COPD.European respiratory review : an official journal of the European Respiratory Society · 2023
    Review
  7. Article
  8. Review
  9. Pharmacological treatment for COPD; GOLD 2017 changes direction.British journal of clinical pharmacology · 2017
    Article
  10. Clinical characteristics of COPD patients with tidal expiratory flow limitation.International journal of chronic obstructive pulmonary disease · 2017
    Article
  11. 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

5 authors at 4 institutions in 2 countries.

Dave SinghMedicines Evaluation Unit, Centre for Respiratory Medicine and Allergy, The University of Manchester and University Hospital of South Manchester NHS Foundation Trust, Manchester, UK.
Massimo CorradiDepartment of Clinical and Experimental Medicine, University of Parma, Parma, Italy.
Monica SpinolaChiesi Farmaceutici, Parma, Italy.
Stefano PetruzzelliChiesi Farmaceutici, Parma, Italy.
Alberto PapiDepartment of Clinical and Experimental Medicine, University of Ferrara, Ferrara, Italy.
Chiesi (Italy) · ITUniversity of Ferrara · ITUniversity of Manchester · GBUniversity of Parma · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A fixed-dose inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) combination of extrafine beclometasone dipropionate and formoterol fumarate (BDP/FF) has been recently approved for use in chronic obstructive pulmonary disease (COPD). Small airway inflammation and remodelling are cardinal features of COPD; therefore, the ability of this extrafine formulation to reach the small, as well as the large, airways is likely to be therapeutically important by enabling treatment of inflammatory processes in the whole bronchial tree. The clinical development of extrafine BDP/FF has demonstrated significant benefits over extrafine FF in terms of lung function improvement and reduction of the exacerbation rate, thus supporting the beneficial effect of an ICS combined to a LABA in COPD patients. Head-to-head comparison studies versus other ICS/LABA combinations have shown that the extrafine formulation enables the clinical benefits to be achieved with a lower dose of ICS. Extrafine BDP/FF showed lung function and dyspnoea improvements comparable to other ICS/LABAs, and a significantly faster onset of action was observed when compared with a salmeterol-containing fixed-dose combination. This review summarises the clinical evidence supporting the efficacy of extrafine BDP/FF in COPD and confirming that extrafine BDP/FF achieves the type of health benefit expected from such a targeted ICS/LABA combination in COPD.

Indexed as

Administration, InhalationBeclomethasoneDrug CombinationsFormoterol FumarateHumansPulmonary Disease, Chronic ObstructiveTreatment OutcomeBeclomethasoneDrug CombinationsFormoterol Fumarate

Identifiers

PMID27309985
PMCPMC4910970
OpenAlexW2428691680

What OpenQuestion holds

Textmetadata
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.